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  • Crédits
Mode Liste Mode Grille
  • Dispositif médical 1003
  • Fabricant 257
  • Événement 124969
  • Implant 20
Rappel de Device Recall Beckman Coulter, Uric Acid Assay
  • Type d'événement
    Recall
  • ID de l'événement
    70030
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1024-2015
  • Date de mise en oeuvre de l'événement
    2014-12-15
  • Date de publication de l'événement
    2015-01-28
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-02-19
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132159
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Acid, uric, uricase (colorimetric) - Product Code KNK
  • Cause
    N-acetyl cysteine (nac), when administered in therapeutic concentrations for the treatment of acetaminophen overdose, interferes with the assays for these analytes: cholesterol osr6x16, uric acid osr6x98, lactate osr6x93, and lipase osr6x30. nac interference may lead to falsely low results.
  • Action
    A customer notification letter was sent to their customers on 12/15/14 to inform them that Beckman Coulter has recently confirmed that N-Acetyl Cysteine (NAC), when administered in therapeutic concentrations (for the treatment of acetaminophen overdose), has been determined to interfere with assays for the following analytes: Cholesterol OSR6X16, Uric Acid OSR6X98, Lactate OSR6X93, and Lipase OSR6X30. The letter informs the customers of the problems identified and the actions to be taken. Customers are instructed to complete and return the enclosed Response Form within 10 days. Customers with questions are instructed to call (800) 223-0130 in the US and Canada. Customers outside the US and Canada are instructed to contact their local Beckman Coulter Representative.
Rappel de Device Recall POWEREASE(TM) Instruments Set Screw Breakoff Instrument
  • Type d'événement
    Recall
  • ID de l'événement
    70032
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0952-2015
  • Date de mise en oeuvre de l'événement
    2014-12-03
  • Date de publication de l'événement
    2015-01-12
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-09-24
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132161
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Instrument, surgical, orthopedic, ac-powered motor and accessory/attachment - Product Code HWE
  • Cause
    The retaining tabs component of the set screw retaining drive may be oversized, which will not allow proper mating between the set screw retaining drive and the set screw.
  • Action
    Medtronic sent an Urgent - Voluntary Market Removal letter dated December 3, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Instructions to Customers: 1.) Please remove the product from normal storage locations. Do not use this product. 2.) As applicable, contact your Medtronic Sales Representative to coordinate the return of affected product. Alternatively, you may call Medtronic's Global Quality Department at (800) 876 -3133, extension 3197 for assistance If you need assistance or have any related questions or concerns, please do not hesitate to contact your Medtronic Sales Representative or the Global Quality Department at (800) 876 - 3133, extension 3197. We sincerely apologize for this inconvenience, but this action is necessary to assure that our high standard of quality is maintained.
Rappel de Device Recall Beckman Coulter, Cholesterol Assay
  • Type d'événement
    Recall
  • ID de l'événement
    70030
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1025-2015
  • Date de mise en oeuvre de l'événement
    2014-12-15
  • Date de publication de l'événement
    2015-01-28
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-02-19
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132162
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Enzymatic esterase--oxidase, cholesterol - Product Code CHH
  • Cause
    N-acetyl cysteine (nac), when administered in therapeutic concentrations for the treatment of acetaminophen overdose, interferes with the assays for these analytes: cholesterol osr6x16, uric acid osr6x98, lactate osr6x93, and lipase osr6x30. nac interference may lead to falsely low results.
  • Action
    A customer notification letter was sent to their customers on 12/15/14 to inform them that Beckman Coulter has recently confirmed that N-Acetyl Cysteine (NAC), when administered in therapeutic concentrations (for the treatment of acetaminophen overdose), has been determined to interfere with assays for the following analytes: Cholesterol OSR6X16, Uric Acid OSR6X98, Lactate OSR6X93, and Lipase OSR6X30. The letter informs the customers of the problems identified and the actions to be taken. Customers are instructed to complete and return the enclosed Response Form within 10 days. Customers with questions are instructed to call (800) 223-0130 in the US and Canada. Customers outside the US and Canada are instructed to contact their local Beckman Coulter Representative.
Rappel de Device Recall Beckman Coulter, Lactate Assay
  • Type d'événement
    Recall
  • ID de l'événement
    70030
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1026-2015
  • Date de mise en oeuvre de l'événement
    2014-12-15
  • Date de publication de l'événement
    2015-01-28
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-02-19
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132163
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Acid, lactic, enzymatic method - Product Code KHP
  • Cause
    N-acetyl cysteine (nac), when administered in therapeutic concentrations for the treatment of acetaminophen overdose, interferes with the assays for these analytes: cholesterol osr6x16, uric acid osr6x98, lactate osr6x93, and lipase osr6x30. nac interference may lead to falsely low results.
  • Action
    A customer notification letter was sent to their customers on 12/15/14 to inform them that Beckman Coulter has recently confirmed that N-Acetyl Cysteine (NAC), when administered in therapeutic concentrations (for the treatment of acetaminophen overdose), has been determined to interfere with assays for the following analytes: Cholesterol OSR6X16, Uric Acid OSR6X98, Lactate OSR6X93, and Lipase OSR6X30. The letter informs the customers of the problems identified and the actions to be taken. Customers are instructed to complete and return the enclosed Response Form within 10 days. Customers with questions are instructed to call (800) 223-0130 in the US and Canada. Customers outside the US and Canada are instructed to contact their local Beckman Coulter Representative.
Rappel de Device Recall Timberline Anchored Lateral Retractable Drill
  • Type d'événement
    Recall
  • ID de l'événement
    70056
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0982-2015
  • Date de mise en oeuvre de l'événement
    2013-08-22
  • Date de publication de l'événement
    2015-01-15
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-03-13
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132193
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Intervertebral fusion device with integrated fixation, lumbar - Product Code OVD
  • Cause
    The outer diameter of the drill shaft is oversized; thereby, resulting in interference fit when inserting the drill into the fixed or variable sleeve assembly.
  • Action
    Distributors and Direct Sales Reps notified via letter to return product.
Rappel de Device Recall MENTOR MemoryGel Sizer
  • Type d'événement
    Recall
  • ID de l'événement
    70042
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0964-2015
  • Date de mise en oeuvre de l'événement
    2014-12-11
  • Date de publication de l'événement
    2015-01-13
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-01-04
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132179
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Sizer, mammary, breast implant volume - Product Code MRD
  • Cause
    The ifu provided in the affected units of the mentor memorygel resterilizable sizer is incorrect. those units include the ifu for the mentor memoryshape resterilizable sizer.
  • Action
    Mentor sent an Important Labeling Correction letter dated December 19, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The firm plans to follow-up with sales representative visits. The recall letter notifies the customer of the issue, but does not instruct them to return the product. Should the customer chose to return the product, all returned product will be tagged to denote no further distribution. The recalled units under firm control have been placed on hold in the inventory system. If you have any questions related to this notice, please contact your local Mentor Sales Representative, or Mentor Customer Service at 1-800-235-5731.
Rappel de Device Recall Fixed Tibial bearing ATTUNE INTUITION Impactor
  • Type d'événement
    Recall
  • ID de l'événement
    70043
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0903-2015
  • Date de mise en oeuvre de l'événement
    2014-11-10
  • Date de publication de l'événement
    2015-01-05
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-12-08
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132180
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Orthopedic manual surgical instrument - Product Code LXH
  • Cause
    Attune intuition impactors (cat. nos. 254401003, 254401004, and 254401006) have broken and produced small pieces. should a fracture occur and not be observed during surgery, there is the potential for these small fractured pieces of the instrument to be left in the patient.
  • Action
    DePuy Synthes sent an Urgent Information letter dated November 10, 2014, to all affected customers. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Customers were instructed to complete the Hospital/User Facility Acknowledgement Car and return to their Deputy Orthopaedics Sales Consultant or fax to 574-371-4939. Customer swere also asked to retain a copy of the complete Acknnowlegement Card in their files along with the notice. Customers with questions were instructed to call 574-371-4917 (M-F; 8 a.m.  5 p.m. EDT). For questions regarding this recall cal 574-371-4917.
Rappel de Device Recall Rotating Tibial Platform ATTUNE INTUITION Impactor
  • Type d'événement
    Recall
  • ID de l'événement
    70043
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0904-2015
  • Date de mise en oeuvre de l'événement
    2014-11-10
  • Date de publication de l'événement
    2015-01-05
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-12-08
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132181
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Orthopedic manual surgical instrument - Product Code LXH
  • Cause
    Attune intuition impactors (cat. nos. 254401003, 254401004, and 254401006) have broken and produced small pieces. should a fracture occur and not be observed during surgery, there is the potential for these small fractured pieces of the instrument to be left in the patient.
  • Action
    DePuy Synthes sent an Urgent Information letter dated November 10, 2014, to all affected customers. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Customers were instructed to complete the Hospital/User Facility Acknowledgement Car and return to their Deputy Orthopaedics Sales Consultant or fax to 574-371-4939. Customer swere also asked to retain a copy of the complete Acknnowlegement Card in their files along with the notice. Customers with questions were instructed to call 574-371-4917 (M-F; 8 a.m.  5 p.m. EDT). For questions regarding this recall cal 574-371-4917.
Rappel de Device Recall Femoral Impactor ATTUNE INTUITION Impactor
  • Type d'événement
    Recall
  • ID de l'événement
    70043
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0905-2015
  • Date de mise en oeuvre de l'événement
    2014-11-10
  • Date de publication de l'événement
    2015-01-05
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-12-08
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132182
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Orthopedic manual surgical instrument - Product Code LXH
  • Cause
    Attune intuition impactors (cat. nos. 254401003, 254401004, and 254401006) have broken and produced small pieces. should a fracture occur and not be observed during surgery, there is the potential for these small fractured pieces of the instrument to be left in the patient.
  • Action
    DePuy Synthes sent an Urgent Information letter dated November 10, 2014, to all affected customers. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Customers were instructed to complete the Hospital/User Facility Acknowledgement Car and return to their Deputy Orthopaedics Sales Consultant or fax to 574-371-4939. Customer swere also asked to retain a copy of the complete Acknnowlegement Card in their files along with the notice. Customers with questions were instructed to call 574-371-4917 (M-F; 8 a.m.  5 p.m. EDT). For questions regarding this recall cal 574-371-4917.
Rappel de Device Recall Roche Molecular Diagnostics
  • Type d'événement
    Recall
  • ID de l'événement
    70058
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-0999-2015
  • Date de mise en oeuvre de l'événement
    2014-12-18
  • Date de publication de l'événement
    2015-06-26
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-02-08
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132194
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Somatic gene mutation detection system - Product Code OWD
  • Cause
    Cobas kras mutation kit t10786 is generating invalid results for the mutant control and/or kras calibrator.
  • Action
    RMS issued an Urgent Field Safety Notice on 12/18/2014. A Quality Notification was provided to all users of the of cobas¿ KRAS Mutation Kit CE-IVD, lots T13091, T15435, T15475, T14777, and W00389, informing them of the issue and instructing them to discontinue use and discard any remaining inventory immediately.
Rappel de Device Recall TiBond
  • Type d'événement
    Recall
  • ID de l'événement
    70044
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0907-2015
  • Date de mise en oeuvre de l'événement
    2014-12-18
  • Date de publication de l'événement
    2015-01-05
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-03-10
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132185
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Intervertebral fusion device with bone graft, lumbar - Product Code MAX
  • Cause
    Spinal elements is recalling the ti-bond related brochures that includes lt-10000 and mp-14000 (all revisions) the content regarding the ti-bond coating within the literature is unsubstantiated in context and/or misleading for the coating's use in spine applications.
  • Action
    Spinal Elements sent an Urgent Field Action letter dated December 22, 2014, to all affected customers. The letter informed the customers to cease all distribution of the literature material. The letter informed the customers that the content regarding the Ti-Bond coating in the literature is unsubstantiated in context and/or misleading for the coating's use in spine applications. In addition to the customer notiification letter, it will include a list of claims related to the field action. The letter also informed customers of the actions to be taken. Customers were instructed to immediately examine their literature inventory, discontinue the use and /or distribution of the affected brochure, destroy all copies or send them back to: Spinal Elements, Inc. 3115 Melrose Drive Carlsbad, CA 92010 If product was further distributed customers should identify those customers and notify them at once. Customers were also instructed to complete and return the enclosed "Customer Response Form." For questions regarding this recall call 760-607-0121, ext 206. Customers with questions were instructed to contact Customer Service at 1-877-SPINALS, ext 213. Customers with questions were instructed to contact Customer Service at (877) SPINAL5 Ext 213.
Rappel de Device Recall Regional Oximetry Sensor
  • Type d'événement
    Recall
  • ID de l'événement
    70045
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0901-2015
  • Date de mise en oeuvre de l'événement
    2014-11-25
  • Date de publication de l'événement
    2014-12-31
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-09-01
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132186
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Oximeter - Product Code DQA
  • Cause
    Nonin medical is conducting a recall of certain regional oximetry sensors and associated products. they have received reports of signal loss during use of our shortcabled regional oximetry sensors with diaphoretic patients. no injury or illness have been reported.
  • Action
    Consignees were sent a Nonin letter dated November 24, 2014. The letter described the problem and the product affected. They requested consignees to discontinue the use of the products and return it to Nonin. Consignees were asked to complete and return the "Medical Device Market Withdrawal Return Response Form". For questions and additional information they can contact James H. Russell at 763-577-2260 or e-mail jim.russell@nonin.com.
Rappel de Device Recall HP LCS IM Hole Locator instrument
  • Type d'événement
    Recall
  • ID de l'événement
    70046
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0908-2015
  • Date de mise en oeuvre de l'événement
    2014-11-12
  • Date de publication de l'événement
    2015-01-05
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-02-24
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132187
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Orthopedic manual surgical instrument - Product Code LXH
  • Cause
    Use of excessive force when impacting may lead to intra-operative femoral fracture.
  • Action
    The firm, DePuy Synthes, sent an "URGENT INFORMATION - DEVICE CORRECTION NOTICE HP LCS IM Hole Locator" notification dated November 12, 2014 to the affected distributors. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. The distributors were instructed to: review the instructions and the information in this notice; provide this notice to your sales consultants, and complete and return the DISTRIBUTOR RESPONSE CARD: Verify Sales Consultant Notifications via fax to (574) 371-4939 or email: kearle@its.jnj.com. For questions, please contact Recall Coordinator, at 574-371-4917 (M-F; 8 a.m. - 5 p.m. EST).
Rappel de Device Recall Covidien Trellis 6 Peripheral Infusion System
  • Type d'événement
    Recall
  • ID de l'événement
    70048
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-1017-2015
  • Date de mise en oeuvre de l'événement
    2014-12-10
  • Date de publication de l'événement
    2015-02-03
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-03-31
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132189
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Catheter, continuous flush - Product Code KRA
  • Cause
    A manufacturing error resulted in the risk of incorrect proximal and distal balloon inflation port identification on the units. units have been identified to have the distal balloon inflation port incorrectly labeled as proximal, and, the proximal balloon port incorrectly labeled as distal.
  • Action
    Consignees were sent an Urgent Product Recall letter dated 12/15/2014. The letter described the issue, identified the affected product, and the required actions. Affected product was to be returned directly to customers' Covidien Sales Rep; or customers were to contact Covidien Service at 1-800-716-6700 to arrange for product return. Questions can be directed to the Covidien Sales Rep or to Covidien Service at 1-800-716-6700. Customers were to complete and return the Verification Form along with the unused product as soon as possible.
Rappel de Device Recall Sysmex XN10 and XN20 Hematology Analyzers
  • Type d'événement
    Recall
  • ID de l'événement
    70054
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1945-2016
  • Date de mise en oeuvre de l'événement
    2014-12-18
  • Date de publication de l'événement
    2016-06-10
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-07-25
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132191
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Counter, differential cell - Product Code GKZ
  • Cause
    There is a potential for elevated hemoglobin (hgb) and impedance platelet count (plt-i) values.
  • Action
    Sysmex Corporation sent a Product Notification Field Correction letter were to all affected customers of record. The letters included instructions for customers to: 1) Review results with an unexpected increase in Hgb, MCH, MCHC, and/or PLT-I. The increase may result in a low or normal value being artificially elevated to either a normal result or a result above the reference ranges, or a high value being artificially increased. There is negligble impact to the RBC when the issue occurs; 2) The relationship with an elevated Hgb would cause the indices (MCH and MCHC) values to appear to be abnormally elevated and may result in the results being flagged for verification or indicated to be outside of reference ranges; 3) Review any "Turbidity/Hgb Interf?" flag which will automatically trigger at an MCHC of 37.5 g/dL; 4) If Hgb is affected, the PLT-I may be also. Review any PLT-I result when an unexpected increase in MCH/MCHC or "Turbidity/Hgb Interf?" flag occurs; 5) Gross interference is likely to trigger a flag, however there is a potential any interference could increase the Hgb or the PLT-I count from a lower level to an "normal" level. Follow laboratory protocol for confirming unexpected results. Customers were further advised that they will be contacted by a Sysmex Field Representative within 180 days to schedule an appointment to replace the rinse cup on the analyzer(s) and that version 00-16 software will be installed to change the rinsing sequence for the aspiration probe. Customers with questions are requested to e-mail the Sysmex Technical Assistance Center. Urgent questions can be answered by calling the Technical Assistance Center at 888-879-7639 (24 hours a day / 7 days a week).
Rappel de Device Recall Merlinhome RF Remote Monitoring Transmitter, Model EX1150, with software...
  • Type d'événement
    Recall
  • ID de l'événement
    70066
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0949-2015
  • Date de mise en oeuvre de l'événement
    2014-12-18
  • Date de publication de l'événement
    2015-01-09
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-03-30
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132201
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Pulse generator, permanent, implantable - Product Code NVZ
  • Cause
    Transmitter may initiate a software reset resulting in backup operation in some implanted st. jude medical radio frequency (rf) enabled implantable cardioverter assura, unify assura, and quadra assura icds and assurity and allure pacemakers.
  • Action
    The firm, St. Jude Medical, sent an "Important Medical Device Correction" Dear Doctor Letter dated 12/18/14 to customers to inform them that the Merlin@home transmitters may initiate a software reset resulting in backup operation in some implanted St. Jude Medical Radio Frequency (RF) enabled Implantable Cardioverter Defibrillators (ICDs) and Pacemakers. The letter informs the customers of the problems identified and the actions to be taken. Customers with questions or concerns are instructed to contact their local St. Jude Medical representative or St. Jude Medical's Technical Services Department at 1-800-722-3774.
Rappel de Device Recall Covidien Trellis 8 Peripheral Infusion System
  • Type d'événement
    Recall
  • ID de l'événement
    70048
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-1018-2015
  • Date de mise en oeuvre de l'événement
    2014-12-10
  • Date de publication de l'événement
    2015-02-03
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-03-31
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132204
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Catheter, continuous flush - Product Code KRA
  • Cause
    A manufacturing error resulted in the risk of incorrect proximal and distal balloon inflation port identification on the units. units have been identified to have the distal balloon inflation port incorrectly labeled as proximal, and, the proximal balloon port incorrectly labeled as distal.
  • Action
    Consignees were sent an Urgent Product Recall letter dated 12/15/2014. The letter described the issue, identified the affected product, and the required actions. Affected product was to be returned directly to customers' Covidien Sales Rep; or customers were to contact Covidien Service at 1-800-716-6700 to arrange for product return. Questions can be directed to the Covidien Sales Rep or to Covidien Service at 1-800-716-6700. Customers were to complete and return the Verification Form along with the unused product as soon as possible.
Rappel de Device Recall CARESCAPE VC150 Vital Signs Monitor
  • Type d'événement
    Recall
  • ID de l'événement
    70068
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1022-2015
  • Date de mise en oeuvre de l'événement
    2014-12-03
  • Date de publication de l'événement
    2015-01-28
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-04-24
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132205
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Monitor,physiological,patient(without arrhythmia detection or alarms) - Product Code MWI
  • Cause
    If the spo2 or rra value is violating the respective alarm limit at the time of switching to monitoring mode, the monitor does not issue visual and audible alarms.
  • Action
    A notification letter was sent to the distributors on 12/3/2014. The letter requests the devices be returned to the manufacturer for repair.
Rappel de Device Recall Timberline Anchored Lateral Retractable Sleeve
  • Type d'événement
    Recall
  • ID de l'événement
    70070
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0983-2015
  • Date de mise en oeuvre de l'événement
    2013-08-22
  • Date de publication de l'événement
    2015-01-15
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-03-13
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132207
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Intervertebral fusion device with integrated fixation, lumbar - Product Code OVD
  • Cause
    The inner diameter of the sleeve shaft is undersized, resulting in interference fit when inserting the anchored lateral straight retractable awl or the anchored lateral straight retractable drill into the sleeve.
  • Action
    The firm, Lanx, sent a letter to their Consignees/customers dated October 15, 2013. The letter describes the product, problem and actions taken. Lanx and their distributors replaced the affected inventory with conforming product. Please contact Chief Compliance Officer at 303-501-8534 or by email: Randy.fesmire@lanx.com if you have any questions regarding this recall.
Rappel de Device Recall GE Healthcare, Discovery IGS 730 & Discovery IGS 740
  • Type d'événement
    Recall
  • ID de l'événement
    70073
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0966-2015
  • Date de mise en oeuvre de l'événement
    2014-12-10
  • Date de publication de l'événement
    2015-01-14
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-06-01
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132213
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Interventional fluoroscopic x-ray system - Product Code OWB
  • Cause
    Potential unintentional system motion or rotation due to a positioning user interface issue with discovery igs 730 and 740 products.
  • Action
    Consignees were sent a 12/10/2014 a GE Healthcare "Urgent Medical Device Correction" letter GEHC Ref# 12223 dated December 10, 2014. The letter was addressed to Hospital Administrators / Risk Managers, Managers of Radiology / Cardiology and Radiologists / Cardiologists. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information ( US call 800-437-1171, other countries contact your local GE Healthcare Service Representative).
Rappel de Device Recall Revolution CT Scanner
  • Type d'événement
    Recall
  • ID de l'événement
    70074
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0985-2015
  • Date de mise en oeuvre de l'événement
    2014-12-19
  • Date de publication de l'événement
    2015-01-15
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-04-29
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132214
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    System, x-ray, tomography, computed - Product Code JAK
  • Cause
    Potential safety issue due to a required torque check on three bolted joints of the revolution ct scanner. no injuries or illnesses reported.
  • Action
    Consignees were sent on 12/19/2014 a GE Healthcare "Urgent Medical Device Correction" letter GEHC # 25457 dated December 19, 2014. The letter was addressed to Hospital Administrators / Risk Managers, Managers of Radiology / Cardiology and Radiologists / Cardiologists. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information (US phone 800-437-1171, Japan 0120-055-919, other countries contact your local GE Healthcare Service Representative).
Rappel de Device Recall HEPFLUSH
  • Type d'événement
    Recall
  • ID de l'événement
    70050
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1032-2015
  • Date de mise en oeuvre de l'événement
    2014-12-19
  • Date de publication de l'événement
    2015-01-29
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-01-26
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132221
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Heparin, vascular access flush - Product Code NZW
  • Cause
    The lot failed ph specification.
  • Action
    Fresenius sent an URGENT DRUG RECALL Letter dated December 19, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. 1. Examine their stock immediately to determine if they have any product from the affected lot. If the consignee is a distributor, immediately notify your customers that have been shipped or may have been shipped this product/lot of this recall and direct them to discontinue distributing or dispensing the affected lot. Please have them prepare to return the product to Fresenius Kabi as instructed in the Urgent Product Recall Response Form. Your customers may retrieve the recall letter and response form at http://www.fresenius-kabi.us /products/pharmaceutical-products/product-updates.html. 2. If you have the affected lot available, immediately discontinue distributing or dispensing the lot, and return all units to Fresenius Kabi ,via FedEx Ground, using the enclosed return goods label and packing slip. A FedEx Ground label can be obtained by checking the box and noting your mailing address on the enclosed Urgent Product Recall Response Form. It will be mailed to the consignee upon receiving the request. A credit memo will be issued covering the quantity of the return to Fresenius Kabi. 3. PLEASE COMPLETE THE ENCLOSED "URGENT PRODUCT RECALL RESPONSE FORM" AND SEND IT BACK TO US IMMEDIATELY VIA EMAIL OR FAX AT 1-708-649-8630. Use the following contact phone numbers as appropriate. Hours of operation: Monday through Friday 8:00 am to 5:00 pm CST: QA Department: (866) 716-2459 for information on how to return product; Vigilance & Medical Affairs: 1(800) 551-7176 for clinical/technical information/Adverse Events (ADE's) reporting.
Rappel de Device Recall Cordis POWERFLEX PRO PTA Dilatation Catheter
  • Type d'événement
    Recall
  • ID de l'événement
    70080
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0998-2015
  • Date de mise en oeuvre de l'événement
    2014-12-22
  • Date de publication de l'événement
    2015-01-16
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-07-09
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132222
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Catheter, angioplasty, peripheral, transluminal - Product Code LIT
  • Cause
    One unit from a demo lot of powerflex pro pta dilatation catheter was left at a hospital and was not sterilized.
  • Action
    The firm, Cordis, sent an "URGENT MEDICAL DEVICE RECALL (Removal)" letter dated December 29, 2014 to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to immediately check their inventory to confirm they do not have any units from the demo lot in possession; identify and set aside any unit from the identified lot; review, complete, sign and return the enclosed Acknowledgement Form directly to Cordis at the fax number on the form; return any affected product to Cordis; share this letter with others in your facility; contact any other facility that has been provided with units of POWERFLEX PRO product; maintain awareness of this notice until all affected product has been returned to Cordis and keep a copy of this notice witn any affected product. For any physician with medical concerns, please contact the Cordis Endovascular Medical Information Line 877-DEVICES Monday through Friday from 9am-5pm. For questions related to the recall that are not adequately addressed in the letter, please contact the Cordis Field Action Coordinator Hal Baden at (786) 313-2365. For questions related to the Acknowledgement Form and its return, please contact Cordis QA at (786) 313-8730.
Rappel de Device Recall EXp Tibial Insert
  • Type d'événement
    Recall
  • ID de l'événement
    70082
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0970-2015
  • Date de mise en oeuvre de l'événement
    2014-12-01
  • Date de publication de l'événement
    2015-01-14
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-05-06
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132223
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
  • Cause
    Difficulty locking exp tibial inserts into tibial trays, caused by a manufacturing condition where a lead in radius on the anterior locking tab is not present on certain insert lots. the absence of this lead in may prevent or make assembly of the insert and tray difficult.
  • Action
    On December 1, 2014, phone calls were made to all direct accounts to notify them of the recall and to request immediate recovery and return of the SC3425 EXp PS Tibial Tray Inserts and SC3453 EXp CR-HF Inserts from their inventory.
Rappel de Device Recall Aesculap Miethke Shunt System
  • Type d'événement
    Recall
  • ID de l'événement
    70086
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1012-2015
  • Date de mise en oeuvre de l'événement
    2014-12-17
  • Date de publication de l'événement
    2015-01-26
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-12-13
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132226
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Shunt, central nervous system and components - Product Code JXG
  • Cause
    Some miethke shunt system accessories may have an incorrect mr safety symbol on the shelf box label. the label should have no symbol but instead is marked with the mr conditional symbol. the product is mr unsafe. this information is only required to be in the instructions for use (ifu).
  • Action
    Aesculap sent an Important Correction and Removal and Field Safety Notification letter, dated December 17, 2014, to all affected customers. The letter identiifed the affected product, problem, and actions to be taken. Customers were requested to remove from inventory and contact Aesculap regarding return of the affected devices and acknowledgement form.
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