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
IV Administration Infusion Sets - Product Code FRN
Cause
It has been determined that with low probability, over-infusion may occur as a result of an open safety clamp fitment (a.K.A. flo-stop fitment) on the pumping segment, whether opened intentionally in the course of expected clinical practice, or as a result of inadvertent action. the over-infusion occurrence is dependent on the user not closing the roller clamp first, as required by clinical practi.
Action
The field action will consist of a mailing and will be conducted through consignees (distributors) in the affected countries as well as direct customers for all IV Administration sets intended for use with Gemini Infusion Pumps and Alaris/Medley Pump modules. The customers and distributors will be notified by registered return receipt mail. For direct customers, separate letters will be sent to the Director of Nursing, Director of Materials and Director of Risk Management at each facility. Distributors will be sent multiple copies of the Safety Alert Notification and Tip Sheets; along with a cover letter outlining their responsibilities to complete the Safety Alert plan and notify their customers as requested.
The domestic letters (direct customers and distributors) were mailed beginning on June 18, 2007 to all of the affected accounts via US Postal Service Certified Mail.
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
Endotracheal Tube - Product Code BTR
Cause
The tubes may kink during use which may impede or prevent ventilation.
Action
Consignees were notified by letter sent via overnight mail on/about June 4, 2007. A follow-up letter was sent to consignees via fax on June 5, 2007. Consignees were instructed to cease distributing the product and return all affected product in inventory to Kimberly-Clark. Distributors were instructed to notify their accounts of the recall. A Product Recall Response Sheet (Packing Slip) was attached to the recall notice.
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
Endotracheal Tube - Product Code BTR
Cause
The tubes may kink during use which may impede or prevent ventilation.
Action
Consignees were notified by letter sent via overnight mail on/about June 4, 2007. A follow-up letter was sent to consignees via fax on June 5, 2007. Consignees were instructed to cease distributing the product and return all affected product in inventory to Kimberly-Clark. Distributors were instructed to notify their accounts of the recall. A Product Recall Response Sheet (Packing Slip) was attached to the recall notice.
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
ophthalmic surgical accessory - Product Code HNO
Cause
Reports have been received of stromal incursions after use of the product.
Action
The firm notified their customers via telephone between 6/8-12/07. During the call, the customer was informed reports had been received of stromal incursions and they were to quit using the product and return it.
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.
Reduced shock- the device may deliver 100 joule (j) to a patient, which is less than the recommended factory minimum default setting of 200 j.
Action
On June 13, 2007 the recalling firm sent a letter dated June 11, 2007, titled URGENT - MEDICAL DEVICE CORRECTIVE ACTION. The letter advises of the situation, recommends to the consignee to set defibrillator to FIXED Sequence Protocol and to contact the firm for a FLEXIBLE Sequence Energy Protocol. The letter provides an instruction sheet and a response sheet to be faxed back to the company.
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
Image-intensified fluoroscopic x-ray system - Product Code JAA
Cause
During routine service, primary and/or secondary collimators may not have been properly reinstalled.
Action
Customers were notified by letter on 03/01/2007. They were told to continue using the machines and that an inspection would be scheduled immediately to verify that collimators had been correctly installed.
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
Needle, Hypodermic, Single Lumen - Product Code FMI
Cause
Needle cannula may separate from the hub during use.
Action
Recall letters requesting product return were mailed to all customers on October 8, 2004
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
Image-intensified fluoroscopic x-ray system - Product Code JAA
Cause
During routine service, primary and/or secondary collimators may not have been properly reinstalled.
Action
Customers were notified by letter on 03/01/2007. They were told to continue using the machines and that an inspection would be scheduled immediately to verify that collimators had been correctly installed.
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
in vitro diagnostic - Product Code GKP
Cause
Acl top unit, when in emergency stop may release liquid during recovery sequence and contaminate sample tube.
Action
Instrumentation Laboratory notiifed the distributor Beckman Coulter on 6/19/2007. Beckman Coulter notified their customers and provided a copy with the Instructions for Recovery Procedure on how to avoid contamination from probe leaks.
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
X-Ray System - Product Code KPR
Cause
The x-ray systems do not indicate the field size when the system's detector is turned off and the collimator is in manual mode. this results in the systems being noncompliant with the field indication performance standards of section 1020.31(e)(2)& (3) of 21code of federal regulations (cfr).
Action
On 2/21/07, Eastman Kodak notified CDRH of its proposed Corrective Action Plan CAP). The CAP was approved by CDRH under the following conditions: (1) Kodak will visit each user facility, and apply dial indicator labels to the collimator knobs, apply a field size label to the collimator housing, and verify that each system complies with the field indication performance standard. (2) Kodak will prepare adequate instructions for the assembly/installation and testing of the dial indicators labels and field size labels. These instructions are to be furnished to all owners of the Kodak Direct View DR 7500 Systems. (3) Kodak will supplement the Kodak DR 7500 system product report with a copy of the adequate instructions. (4) Kodak will perform 100% verification of the recall effectiveness. (5) Kodak will not charge for the corrections and will reimburse the owner for any out-of-pocket expenses. (6) Kodak will notify the manufacturer of the Ralco 302 ACS collimators, Ralco, that the collimator is noncompliant with the performance standard. Kodak has reported that the CAP was completed as of 5/07/07.
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
Defibrillator/Monitor - Product Code MKJ
Cause
The ecg signal may become unusable to assess patient condition and need for therapy.
Action
Philips Medical contacted accounts by letter dated June 11, 2007. Users are advised to remove product from service, if possible. If not, a back up unit should be available to use. Service reps will contact accounts to replace units.
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 - Product Code DXE
Cause
Mislabeling : possis angiojet xvg catheter thrombectomy sets display incorrect information on the outer packaging box and also on the inner sterile tray. the labeling incorrectly states that the unit is indicated for use in coronary vessels. these units should indicated use only for peripheral arteries.
Action
A Urgent Medical Device recall letter dated 19 June 2007, was sent to consignees advising that all unused product be removed and returned to Possis. An acknowledgement of the disposiiton of the product will be requested from consignees.
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
X Ray System - Product Code KPR
Cause
The x-ray systems do not indicate the field size when the system's detector is turned off and the collimator is in manual mode. this results in the systems being noncompliant with the field indication performance standards of section 1020.31(e)(2)& (3) of 21code of federal regulations (cfr).
Action
On 3/06/07, Eastman Kodak notified CDRH of its proposed Corrective Action Plan (CAP). The CAP was approved by CDRH under the following conditions: (1) Kodak will visit each user facility, and apply dial indicator labels to the collimator knobs, apply a field size label to the collimator housing, and verify that each system complies with the field indication performance standard. (2) Kodak will prepare adequate instructions for the assembly/installation and testing of the dial indicators labels and field size labels. These instructions are to be furnished to all owners of the Kodak Direct View DR3000 Systems. (3) Kodak will supplement the Kodak DR3000 system product report with a copy of the adequate instructions. (4) Kodak will perform 100% verification of the recall effectiveness. (5) Kodak will not charge for the corrections and will reimburse the owner for any out-of-pocket expenses. (6) Kodak will notify the manufacturer of the Ralco 302 ACS collimators, Ralco, that the collimator is noncompliant with the performance standard.
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
Intravascular Administration Set - Product Code FPA
Cause
Risk of leakage: when the phaseal protector and injector are used with drug vials with thick rubber stoppers which have a concave upper surface and a flat bottom surface there is a potential for leakage. these rubber stoppers are made of a harder rubber formulation and may be more difficult to penetrate.
Action
On or about 6/15/2007, the firm sent advisory notice letters to the end users and the instructions for use have been updated by adding a precaution statement regarding the use of thick rubber stoppers. The firm is also updating the customer training program to include how to handle drug vials with thick concave rubber stoppers.
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
Intravascular Administration Set - Product Code FPA
Cause
Risk of leakage: when the phaseal protector and injector are used with drug vials with thick rubber stoppers which have a concave upper surface and a flat bottom surface there is a potential for leakage. these rubber stoppers are made of a harder rubber formulation and may be more difficult to penetrate.
Action
On or about 6/15/2007, the firm sent advisory notice letters to the end users and the instructions for use have been updated by adding a precaution statement regarding the use of thick rubber stoppers. The firm is also updating the customer training program to include how to handle drug vials with thick concave rubber stoppers.
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
Hospital Bed - Product Code FIN
Cause
False latch/failure to latch-the side rail may not latch, or the latch may not fully engage, resulting in the siderail being able to be lowered without pulling on the release handle.
Action
The firm notified consignees via an Urgent Device Correction letter dated 11/12/07 informing them of the problem and informed them they would be receiving upgrade kits which they could have their qualified personnel install themselves following video instructions also provided, or they could contact Hill-Rom for assistance.
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
surgical suture - Product Code GDF
Cause
There is a potential for the pouch to become damaged during shipping, compromising the sterility of the device inside.
Action
Consignees were sent a letter on June 19, 2007. The letter identified the product and problem. The letter also included a form for inventory purposes which is to be completed and faxed to Synovis.
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
surgical suture - Product Code GDF
Cause
There is a potential for the pouch to become damaged during shipping, compromising the sterility of the device inside.
Action
Consignees were sent a letter on June 19, 2007. The letter identified the product and problem. The letter also included a form for inventory purposes which is to be completed and faxed to Synovis.
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
surgical suture - Product Code GDF
Cause
There is a potential for the pouch to become damaged during shipping, compromising the sterility of the device inside.
Action
Consignees were sent a letter on June 19, 2007. The letter identified the product and problem. The letter also included a form for inventory purposes which is to be completed and faxed to Synovis.
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
surgical suture - Product Code GDF
Cause
There is a potential for the pouch to become damaged during shipping, compromising the sterility of the device inside.
Action
Consignees were sent a letter on June 19, 2007. The letter identified the product and problem. The letter also included a form for inventory purposes which is to be completed and faxed to Synovis.
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
surgical suture - Product Code GDF
Cause
There is a potential for the pouch to become damaged during shipping, compromising the sterility of the device inside.
Action
Consignees were sent a letter on June 19, 2007. The letter identified the product and problem. The letter also included a form for inventory purposes which is to be completed and faxed to Synovis.
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
surgical suture - Product Code GDF
Cause
There is a potential for the pouch to become damaged during shipping, compromising the sterility of the device inside.
Action
Consignees were sent a letter on June 19, 2007. The letter identified the product and problem. The letter also included a form for inventory purposes which is to be completed and faxed to Synovis.
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
Computed tomography scanner - Product Code JAK
Cause
Two potential artifacts may appear in some images from head scans on the brilliance 40/64 systems. these artifacts may lead to misdiagnosis.
Action
Firm notified its customers via a Product Safety Notification letter dated May 25, 2007, warning the user of a possible appearance of artifacts which could lead to a misdiagnosis and improper treatment.
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
Computed tomography scanner - Product Code JAK
Cause
Two potential artifacts may appear in some images from head scans on the brilliance 40/64 systems. these artifacts may lead to misdiagnosis.
Action
Firm notified its customers via a Product Safety Notification letter dated May 25, 2007, warning the user of a possible appearance of artifacts which could lead to a misdiagnosis and improper treatment.
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
Intravascular Administration Set - Product Code FPA
Cause
Risk of leakage: when the phaseal protector and injector are used with drug vials with thick rubber stoppers which have a concave upper surface and a flat bottom surface there is a potential for leakage. these rubber stoppers are made of a harder rubber formulation and may be more difficult to penetrate.
Action
On or about 6/15/2007, the firm sent advisory notice letters to the end users and the instructions for use have been updated by adding a precaution statement regarding the use of thick rubber stoppers. The firm is also updating the customer training program to include how to handle drug vials with thick concave rubber stoppers.