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
Apparatus, autotransfusion - Product Code CAC
Cause
The label on the tyvek bag is missing. this is used by customers to identify material code, lot number, and expiration date once the product is removed from the shipper box.
Action
Teleflex sent an Urgent Medical Device Recall Notification dated March 30, 2016 to customers and distributors. The letter identified the affected product, problem and actions to be taken. The letter requested that they discontinue use and quarantine any products. The letter instructed customers to complete the enclosed Recall Acknowledgment Form and fax it to 1-855-419-8507, Attn: Customer Service or email to recalls@teleflex.com.. For questions contact your local sales representative or Customer Service at 1-866-246-6990.
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.
Medtronic is conducting a voluntary urgent medical device recall of two lots of the powercross 0.018" ¿ over the wire (otw) percutaneous transluminal angioplasty (pta) dilatation catheter because the product is mislabeled.
Action
Consignees were sent on 3/29/2016 a Medtronic "Urgent Medical Device Recall" letter dated March 2016. The letter was addressed to Risk Manger or Health Care Professional.
The letter described the problem and the product involved in the recall.
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.
Firm's quarterly dose audit testing showed that one batch was radiated below the augmented dose and therefore did not meet the augmented dose of 28.4 kgy.
Action
Hansen Medical sent an Urgent Notice Product Recall notification dated March 28, 2016, to all affected customers. The notification identified the product, the problem, and the action to be taken by the customer. Customers were instructed to provide the product to the Hansen Medical field representative to assure credit appropriately applied to their account. Customers with questions were instructed to contact their local Hansen Medical representative or call 650-404-5581.
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
unknown device name - Product Code N/A
Cause
It has been determined that the onset mixing pen has an optimal use period of 18 months from start of use. however, the current labeling and ifu does not stipulate this time period.
Action
Valeant sent a letter entitled "Field Correction to Orapharma Onset Mixing Pen," dated 1/29/2016, to customers via UPS. The letter identified the affected device and the issue involved. The firm recommends that users stop using the device if it had been in use for more than 18 months. Customers were to refer to the list of the affected lots to determine if their device needed to be replaced. If the device was one of the ones identified, users were to contact Valeant Pharmaceuticals to arrange for a replacement at no charge. Questions should be directed to customer service 800-321-4576.
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
Clinical sample concentrator - Product Code JJH
Cause
The hand-held barcode scanner model it3800 used with the cobas ampliprep instrument mis-identified a sample barcode id.
Action
Roche Molecular Systems sent an "Urgent Medical Device Correction (UMDC) notification letter dated March 3, 2016, to their affected customers. Customers were instructed to provide the UMDC to other affected parties who may need to be aware of this issue. Customers were asked to complete the attached fax form and fax it to 1-866-737-5396. Customers with questions should contact Roche Support Network Customer Support Center at 1-800-526-1247. For questions regarding this recall call 908-253-7200.
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.
Reports relating to unintended patient or operator burns or operator electric shock for some of integra's microfrance electrosurgical instruments.
Action
Integra sent an "Urgent Medical Device Correction" Field Safety Notice and an addendum dated March 7, 2016 to their customers via traceable courier service.
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.
Reports relating to unintended patient or operator burns or operator electric shock for some of integra's microfrance electrosurgical instruments.
Action
Integra sent an "Urgent Medical Device Correction" Field Safety Notice and an addendum dated March 7, 2016 to their customers via traceable courier service.
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
Electrode, depth - Product Code IKD
Cause
Ad-tech is recalling unopened/unused sterile cables intended to be used only with all compatible ad-tech electrodes for the purpose of connecting these electrodes to third party monitors/stimulators. this recall has been initiated due to package failures (i.E. compromised sterile barriers) that were identified during the execution of a shipping simulation investigation.
Action
Consignees were sent a "Medical Device Recall" letter dated March 29, 2016. The letter described the problem and the product being recalled. Advised consignees to immediately examine their inventory, quarantine and return the product to AD-Tech. If the product has been further distributed identify customers and notify them of the recall. Requested consignees to complete and return the "Medical Device Recall Return Response" form to their Ad-Tech Clinical Specialist at customersupport@adtechmedical.com; FAX: 262-634-5668 or Telephone 262-634-1555. For questions contact Ad-Tech Clinical Specialist.
.
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
Culture media, selective and non-differential - Product Code JSJ
Cause
Performance failure; poor hemolytic reaction of non or weakly hemolytic group b streptococcus (gbs) with the target qc organism, streptococcus agalactiae (atcc 13813) due to product deterioration.
Action
On 03/21/2016 customers were notified by phone, and were sent a notification letter.
Customers were instructed via phone call to discard remaining plates of the implicated lot, and to notify the firm of how many plates are left. The firm stated that they will be issuing replacements. The firm stated that they will be sending written notification as well. The firm requested full name and e-mail or fax number in order to follow-up with the written notification.
The customer notification letter instructs customers to complete, sign, scan/e-mail or fax back enclosed form stating compliance with the action regarding the specific lot. The firm requests the form be returned to the attention of the Quality Assurance Department at techservice@hardydiagnostics.com, fax number 805-614-9274. If the lab is unable to be reached via telephone and would like replacements or credit contact Customer Service Department at 800-266-2222, option 1. Replacements will be sent out at no charge.
Any questions contact Technical Services Department at 800-266-2222, option 2 or via e-mail at techservice@hardydiagnostics.com.
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
Device, dermal replacement - Product Code MDD
Cause
Integra's post qa release review of historical product release test results for meshed idrt products identified the peel strength test average result was incorrectly calculated for a single lot (lot 105a00324750).
Action
Integra LifeSciences Inc. sent an urgent voluntary medical device recall letter/recall acknowledgement and return form dated March 11. 2016. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review their inventory for the affected product and immediately stop using and remove from service. Customers were asked to complete the attached form and return by email or fax as indicated on the form. Customers with questions were advised to contact Customer Service at 1-888-601-0203.
For questions regarding this recall call 609-275-2700.
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,intravascular,therapeutic,short-term less than 30 days - Product Code FOZ
Cause
The device may have a defect in the catheter. in some instances this defect could result in catheter
separation or breakage.
Action
BD isssued an urgent voluntary product recall lettter/recall response card on 3/18/2016.
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
Couch, radiation therapy, powered - Product Code JAI
Cause
When using the recalled product in split shift mode, the non-sub-millimeter positioning has been found to be inconsistent with the setting parameters.
Action
Civco Medical Solutions sent a "Urgent Field Correction Notice" dated March 31, 2016, to all affected customers. The letter identified the product the problem and the action need to be taken by the customer.
The software's other configuration, "All 6 Degrees Protura" does not have the same translational issues. The firm send notification letters on February 23, 2016. In this letter, the Product Manager verified each site's software is configured to this operational mode which operates without the identified problem. In a later and separate notification on March 31, 2016, the firm informed customers that a new software version will be installed to address the problem. No timeframe was given in the letter.
For further questions, please call ( 712) 737-8688.
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.
Panorama central station including the work station view station, view station and the egateway will revert to the year 2000 when daylight savings time (dst) occurs on march 13, 2016, or under various conditions.
Action
Mindray DS USA Inc. issued a Medical Device Service Notice dated March 9, 2016. The letter identified the product, the problem, and the action to be taken by the customer. Customers requiring technical assistance were instructed to contact Mindray's Technical Support team at 1-800-288-2121. Mindray will address the systems response to DST in a future software update which will be provided to the customer at no cost.
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
Bandage, elastic - Product Code FQM
Cause
The product lot did not meet sterility requirements based on fda sampling and analysis.
Action
The firm, AMD-Ritmed, sent an "URGENT: MEDICAL DEVICE RECALL" letter dated 3/30/2016 and Medical Device Recall Response Form to the US distributors/customers via e-mail. The letter described the product, problem and actions to be taken. The customers were instructed to examine your stock to determine if you have any; immediately discontinue distributing product; promptly return product via parcel post to Tonawanda/Buffalo warehouse, ATTENTION: RETURNED GOODS, AMD-Ritmed Inc., 295 Firetower Drive, Tonawanda, NY 14150; if you have further distributed the product, immediately contact your accounts, advise them of the recall situation and have them return their outstanding stock, and complete and return the enclosed MEDICAL DEVICE RECALL RETURN RESPONSE-Acknowledgment & Receipt Form via email to : AMDCUSTOMERSERVICE@AMDRITMED.COM or fax to: 1-866-871-3455, ATTN: AMD-Ritmed Customer Service.
If you have any questions, please contact us at (1-800-445-0340) or at AMD Customer Service AMDCustomerService@amdritmed.com.
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
An error was found within the hungarian translations of the cobas¿ egfr mutation test v2 instructions for use (m/n
07340761001-01hu, doc rev. 1.0, dated 08/2015) and the cobas¿ cfdna sample preparation kit instructions for use
(m/n 07573758001-01hu, doc. rev. 1.0, dated 05/2015).
Action
Roche Molecular Diagnostics Inc. issued an Urgent Field Safety Notice dated March 15, 2016 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Actions to be taken by the customer:
" If you have utilized 2 ¿L of DNA PBB during testing of plasma specimens, the samples must be retested using the correct volume (2mL DNA PBB).
Communication of this Field Safety Corrective Action
This notice must be passed on to all those who need to be aware within your organization or to any organization/individual where the potentially affected devices have been distributed/supplied.
Please maintain awareness of this notice and resulting action for an appropriate period to ensure the effectiveness of the corrective action.
The undersigned confirms that this notice has been notified to the appropriate Regulatory Agency.
For questions regarding this recall call 908-253-7200.
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.
Potential for the weld to fail at the pivot point of the monitor bracket. this weld failure could cause the display interface and bracket to fall from its mounted location, resulting in injury.
Action
Skytron LLC initiated a voluntary recall of twenty-four monitor brackets used as a mounting point for display interfaces utilized in clinical applications for viewing purposes and to provide an articulating point of movement on the ceiling mounted radial arm suspension system of the Ergon 3 equipment pendant /booms via telephone calls to customers, and written notices sent via certified USPS mail on 04/01/2016.
All potentially affected users will receive a field correction notification directly from Skytron, LLC along with the contact information of their local Skytron distributor. Skytron distributors must contact identified users within the universe of affected products to schedule a time replace the affected monitor bracket(s).
Skytron will provide a replacement of the monitor bracket. The replacement monitor bracket(s) and installation must be conducted by you, the Skytron distributor. The affected monitor bracket(s) and Service Report indicating that the monitor bracket(s) was replaced must be returned to Skytron.
Please contact Larry Perez, Vice President of Technical Services, at 616-656-1187 or lperez@skytron.us, or Thao Selleck, Complaint Resolution Analyst, at 616-656-6403 or tselleck@skytron.us with any questions. For after-hours support, please call 1-800-SKYTRON.
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.
The incorrect dfu was packaged with two lots of gdc 360 degree detachable coils.
Action
The firm, Stryker Neurovascular, sent an "URGENT: Field Safety Notification" dated 3/21/2016 via courier to its consignees/customers. The notification describes the product, problem and actions to be taken. The customers were instructed to immediately check your inventory; follow the instructions listed in the Directions For Use (DFU); circulate and maintain the notice internally to all interested/affected parties; inform Stryker if any of the subject devices have been distributed; complete and return the FIELD SAFETY CORRECTIVE ACTION AKNOWLEDGMENT FORM to Stryker via fax at 1 (866) 876-4355 within 7 calendar days, as well as notify any other organizations that the device may have been distributed to.
Should you have any queries concerning this matter contact Quality Manager at 510-413-2593 or email: Geraldine.ahern@stryker.com
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
Software defect causing intermittently slow response of host.
Action
On 3/24/2016 the firm mailed Customer Information letters to their customers.
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.
The incorrect dfu was packaged with two lots of gdc 360 degree detachable coils.
Action
The firm, Stryker Neurovascular, sent an "URGENT: Field Safety Notification" dated 3/21/2016 via courier to its consignees/customers. The notification describes the product, problem and actions to be taken. The customers were instructed to immediately check your inventory; follow the instructions listed in the Directions For Use (DFU); circulate and maintain the notice internally to all interested/affected parties; inform Stryker if any of the subject devices have been distributed; complete and return the FIELD SAFETY CORRECTIVE ACTION AKNOWLEDGMENT FORM to Stryker via fax at 1 (866) 876-4355 within 7 calendar days, as well as notify any other organizations that the device may have been distributed to.
Should you have any queries concerning this matter contact Quality Manager at 510-413-2593 or email: Geraldine.ahern@stryker.com
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
Wire, guide, catheter - Product Code DQX
Cause
Boston scientific is voluntarily implementing a medical device recall of one batch of pt graphix magnet j-tip guidewires. boston scientific has found that, while the batch is labeled as a j-tip model, the guidewires are straight and do not have the pre-formed j-tip. the most severe injury expected to occur is a limited procedure delay caused by the need to replace the guidewire with one that has.
Action
Boston Scientific sent an "Urgent Medical Device Recall" letter dated March 28, 2016. The letter was addressed to Cath Lab Materials Manager / Field Action Contact. The letter described the problem and the product affected by the recall. Advised consignees to cease immediately further distribution or use of the product and to notify their customers. They also requested consignees to complete and return "The Reply Verification Tracking Form" For questions contact your local Boston scientific sales Representative of the Boston Scientific Filed Action Center..
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.
American Surgical issued an Urgent Recall and Field Safety Notice letter
dated March 31, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were provided instruction to address affected devices in their inventory. They should address this by either selecting Action A or B:
Action A: Users should perform a check of the device before use and, as stated in the IFU, patties should not be used if in an open or damaged pouch. For the affected lots, special attention should be given to lower portion of the pouch where the Tyvek and clear film are sealed.
Action B: Place the affected lots in quarantine and contact American Surgical Company for an RMA and replacement. All affected devices are eligible for replacement by ASC.
Complete and return confirmation of actions described in Field Safety Notice.
Contact:Tel: 1-800-343-0060 Option 2, Fax: 781-595-5460
Email: CustomerService@AmericanSurgical.com
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.
American Surgical issued an Urgent Recall and Field Safety Notice letter
dated March 31, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were provided instruction to address affected devices in their inventory. They should address this by either selecting Action A or B:
Action A: Users should perform a check of the device before use and, as stated in the IFU, patties should not be used if in an open or damaged pouch. For the affected lots, special attention should be given to lower portion of the pouch where the Tyvek and clear film are sealed.
Action B: Place the affected lots in quarantine and contact American Surgical Company for an RMA and replacement. All affected devices are eligible for replacement by ASC.
Complete and return confirmation of actions described in Field Safety Notice.
Contact:Tel: 1-800-343-0060 Option 2, Fax: 781-595-5460
Email: CustomerService@AmericanSurgical.com
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
Software defect causing intermittently slow response of host.
Action
On 3/24/2016 the firm mailed Customer Information letters to their customers.
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.
Potential for unexpected motion of the xi stapler jaws on the da vinci xi system with p5 software relating to a combination of the p5 software and the surgeon quickly transitioning from the clamp to the fire pedal during use.
Action
Intuitive Surgical sent an Urgent Product Safety notification to customers via e-mail on March 25, 2016. Customers were advised to STOP USE on the EndoWrist Stapler 45 and 30 instruments on da Vinci XI systems with p5 software. Product letters followed and were mailed on March 31, 2016 by Fed Ex.
Urgent Medical Device letters were sent via Fed Ex on March 31, 2016 (dated April 1, 2016). These letters reiterated what was explained in the previous e-mail and provide more information of the unexpected motion issue. In addition to the stop use request, letters requested that all personnel be fully informed of the issue.
Further information or support concerning this issue, please contact your Clinical Sales Representative or contact ISI Customer Service at the number:
North America: 800-876-1310 Option 3 (6 am to 5pm PST)
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
Drill, surgical, ent (electric or pneumatic) including handpiece - Product Code ERL
Cause
Certain lots of the otologic curved micro (ocm) diamond ball burrs may be missing the diamond coating and the ball may be the incorrect size.
Action
Consignees were sent an Urgent Notice of this Medical Device Recall on 3/28/2016 for their product Otologic Curved Micro (OCM) Diamond Ball Burr, with the following actions required: We have record that your facility has the product(s) subject to this recall (removal). DePuy Synthes asks that you review your inventory and immediately remove the affected lots from stock.
Please take the following actions: If you DO HAVE any of the identified devices, please take the following steps: Complete the Verification Section (page 3 of this letter) by checking the appropriate box indicating affected product has been located. Also, please indicate the number of devices found and note the Return Authorization Number. Please include your name, title, address, telephone number and signature in the spaces provided. Please contact Product Support at (800) 327-6887, option 1, to arrange for return of any unused product. A credit will be issued for returned product. Send a copy of the completed Verification Section (page 3) to Product Support by fax to (561) 627-2682. Send a copy of the completed Verification Section (page 3) to the Complaint Handling Unit by
scan/email to RA-DPYUS-chu.pb@ITS.JNJ.com. If you DO NOT HAVE the identified product, please take the following steps: Complete the Verification Section by checking the appropriate box indicating that no affected product has been located. Please include your name, title, address, telephone number and signature in the spaces provided. This return documentation acknowledges
your receipt of medical device recall (removal) information.
¿ Return the documents to The Anspach Effort by:
¿ Fax: (561) 627-2682
¿ Scan/email: RA-DPYUS-chu.pb@ITS.JNJ.com
¿ Giving them to your DePuy Synthes Sales Consultant
¿ Note: If the Verification Section is answered on behalf of more than one facility and/or individual, please clearly indicate the name and address of the facility and/or individual of the notification.