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.
Notas adicionales en la data
Hip Prosthesis Component - Product Code KWL
Causa
Incorrect part: device may have an incorrect locking ring assembled with the uhr bipolar head.
Acción
Stryker sent Urgent Product Hold letters to US branches/agencies and hospitals on October 26, 2007 advising them to quarantine the product from these lots, and Urgent Product Recall letters on November 2, 2007 advising them to return the devices to Stryker. International distributors were sent an advisory on November 6, 2007.
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.
Notas adicionales en la data
Hip Prosthesis Component - Product Code KWL
Causa
Incorrect part: device may have an incorrect locking ring assembled with the uhr bipolar head.
Acción
Stryker sent Urgent Product Hold letters to US branches/agencies and hospitals on October 26, 2007 advising them to quarantine the product from these lots, and Urgent Product Recall letters on November 2, 2007 advising them to return the devices to Stryker. International distributors were sent an advisory on November 6, 2007.
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.
Notas adicionales en la data
Hip Prosthesis Component - Product Code KWL
Causa
Incorrect part: device may have an incorrect locking ring assembled with the uhr bipolar head.
Acción
Stryker sent Urgent Product Hold letters to US branches/agencies and hospitals on October 26, 2007 advising them to quarantine the product from these lots, and Urgent Product Recall letters on November 2, 2007 advising them to return the devices to Stryker. International distributors were sent an advisory on November 6, 2007.
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.
Notas adicionales en la data
Hip Prosthesis Component - Product Code KWL
Causa
Incorrect part: device may have an incorrect locking ring assembled with the uhr bipolar head.
Acción
Stryker sent Urgent Product Hold letters to US branches/agencies and hospitals on October 26, 2007 advising them to quarantine the product from these lots, and Urgent Product Recall letters on November 2, 2007 advising them to return the devices to Stryker. International distributors were sent an advisory on November 6, 2007.
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.
Notas adicionales en la data
Hip Prosthesis Component - Product Code KWL
Causa
Incorrect part: device may have an incorrect locking ring assembled with the uhr bipolar head.
Acción
Stryker sent Urgent Product Hold letters to US branches/agencies and hospitals on October 26, 2007 advising them to quarantine the product from these lots, and Urgent Product Recall letters on November 2, 2007 advising them to return the devices to Stryker. International distributors were sent an advisory on November 6, 2007.
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.
Notas adicionales en la data
Hip Prosthesis Component - Product Code KWL
Causa
Incorrect part: device may have an incorrect locking ring assembled with the uhr bipolar head.
Acción
Stryker sent Urgent Product Hold letters to US branches/agencies and hospitals on October 26, 2007 advising them to quarantine the product from these lots, and Urgent Product Recall letters on November 2, 2007 advising them to return the devices to Stryker. International distributors were sent an advisory on November 6, 2007.
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.
Notas adicionales en la data
Hip Prosthesis Component - Product Code KWL
Causa
Incorrect part: device may have an incorrect locking ring assembled with the uhr bipolar head.
Acción
Stryker sent Urgent Product Hold letters to US branches/agencies and hospitals on October 26, 2007 advising them to quarantine the product from these lots, and Urgent Product Recall letters on November 2, 2007 advising them to return the devices to Stryker. International distributors were sent an advisory on November 6, 2007.
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.
Expiration date for sterility; the 5 year dating could not be validated/supported for sterility assurance.
Acción
All customers were contacted by telephone starting 9/13/2007. They were asked to return all Tucker family of catheters and all Morton IUI catheters that are on the shelves. A UPS call tag was sent to each customer to facilitate the return of the products. A follow up Urgent Device Recall letter was sent to all customers on 10/9/2007 reminding them to return all outstanding inventory when the UPS call tag arrives.
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.
Expiration date for sterility; the 5 year dating could not be validated/supported for sterility assurance.
Acción
All customers were contacted by telephone starting 9/13/2007. They were asked to return all Tucker family of catheters and all Morton IUI catheters that are on the shelves. A UPS call tag was sent to each customer to facilitate the return of the products. A follow up Urgent Device Recall letter was sent to all customers on 10/9/2007 reminding them to return all outstanding inventory when the UPS call tag arrives.
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.
Expiration date for sterility; the 5 year dating could not be validated/supported for sterility assurance.
Acción
All customers were contacted by telephone starting 9/13/2007. They were asked to return all Tucker family of catheters and all Morton IUI catheters that are on the shelves. A UPS call tag was sent to each customer to facilitate the return of the products. A follow up Urgent Device Recall letter was sent to all customers on 10/9/2007 reminding them to return all outstanding inventory when the UPS call tag arrives.
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.
Expiration date for sterility; the 5 year dating could not be validated/supported for sterility assurance.
Acción
All customers were contacted by telephone starting 9/13/2007. They were asked to return all Tucker family of catheters and all Morton IUI catheters that are on the shelves. A UPS call tag was sent to each customer to facilitate the return of the products. A follow up Urgent Device Recall letter was sent to all customers on 10/9/2007 reminding them to return all outstanding inventory when the UPS call tag arrives.
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.
Notas adicionales en la data
power supply for in vitro diagnostic - Product Code JJE
Causa
Electrical grounding failure: during manufacturing, internal testing found one instrument wlth an intermittent failure of
the electrical grounding. the source of the problem was traced to inadequate soldering.
Acción
Beckman Coulter mailed a Product Corrective Action (PCA) letter on October 17, 2007 to all Access and Access 2 lmmunoassay Systems, SYNCHRON LXi 725 System, and UniCel DxC 600i System customers.
The customers were informed that during manufacturing, internal testing found one instrument wlth an intermittent failure of
the electrical grounding. The source of the problem was traced to inadequate soldering. The letter referenced a
proactive initiative to inspect the power supply sled assemblies
on all instruments referenced. A response form was included.
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.
Notas adicionales en la data
in vitro diagnostic - Product Code JJE
Causa
Incorrect results: there is an increased variance in assay performance when the unicel dxl 800 modification (mod id 10027)
and/or unicel dxl 800 modification (mod id 6733) have been implemented and there are room fluctuations after assay calibration between the extremes of the 18¿c and 32¿c operating range.
Acción
Beckman Coulter mailed a Product Corrective Action (PCA) letter the week of
October 8, 2007 to the customers who have the affected UniCel Dxl 800
Access lmmunoassay systems advising that there is an increased variance in assay performance when the UniCel Dxl 800 Modification (MOD ID 10027)
and/or UniCel Dxl 800 Modification (MOD ID 6733) have been implemented and there are room fluctuations after assay calibration between the extremes of the 18¿C and 32¿C operating range. The letter further advises that Beckman Coulter will contact the customer to arrange a date to remove the modificatlons but until the modification is completed, the system should be operated in a
room temperature of 20¿C to 30¿C. This can be acomplished by monitoring
and recording room tamperature in the area of the instrument. Customers are also asked to review historical quality control records to ensure assay performance is within their laboratory specification and that patient results should be reviewed in context of other diagnostics tests and the clinical presentations of the patient. A response form is included.
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.
Notas adicionales en la data
Angiography X-Ray - Product Code IZI
Causa
Incorrect contour finding: image may be calibrated to the wrong size catheter.
Acción
Siemens issued a Customer Safety Advisory Notice dated 8/29/08 to inform customers of the potential issue. The recalling firm issued Update Instructions AX040/08/S to the service engineers which provides information to fix the problem.
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.
Notas adicionales en la data
Stretcher - Product Code FPO
Causa
Brake problems: the stretcher brake cams may crack while attempting to lock the stretcher brake (sechrist is supplied the stretchers by the manufacturer stryker medical).
Acción
Urgent Medical Device Correction letters were sent to customers beginning on November 9, 2007, via FedEx & DHL overnight. Customers were notified this action was being taken to providing notification to their customers as a continued implementation of the Stryker Medical field correction.
The Notification letter instructed their customers to:
1. Locate the gurneys with the serial numbers listed in this advisory.
2. If any of the affected gurneys cannot be located, determine if they have been sold, transferred, or donated to another facility and notify us regarding their new location.
3. Verify the brakes are working properly. The brake function may be checked by engaging the brake pedal and pushing on each end of the gurney to make sure that casters are locked securely.
4. Remove the gurneys with non-functioning brakes from service until brake cams have been replaced and brakes are fully functional.
5. Contract Sechrist for the replacement parts package.
6. Complete the retrofit of the Gurney.
7. Verify correct function of the brake assembly following retrofit.
8. Complete and send the Correction Verification Form contained in the package to Sechrist.
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.
Notas adicionales en la data
Stretcher - Product Code FPO
Causa
Brake problems: the stretcher brake cams may crack while attempting to lock the stretcher brake (sechrist is supplied the stretchers by the manufacturer stryker medical).
Acción
Urgent Medical Device Correction letters were sent to customers beginning on November 9, 2007, via FedEx & DHL overnight. Customers were notified this action was being taken to providing notification to their customers as a continued implementation of the Stryker Medical field correction.
The Notification letter instructed their customers to:
1. Locate the gurneys with the serial numbers listed in this advisory.
2. If any of the affected gurneys cannot be located, determine if they have been sold, transferred, or donated to another facility and notify us regarding their new location.
3. Verify the brakes are working properly. The brake function may be checked by engaging the brake pedal and pushing on each end of the gurney to make sure that casters are locked securely.
4. Remove the gurneys with non-functioning brakes from service until brake cams have been replaced and brakes are fully functional.
5. Contract Sechrist for the replacement parts package.
6. Complete the retrofit of the Gurney.
7. Verify correct function of the brake assembly following retrofit.
8. Complete and send the Correction Verification Form contained in the package to Sechrist.
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.
Notas adicionales en la data
Stretcher - Product Code FPO
Causa
Brake problems: the stretcher brake cams may crack while attempting to lock the stretcher brake (sechrist is supplied the stretchers by the manufacturer stryker medical).
Acción
Urgent Medical Device Correction letters were sent to customers beginning on November 9, 2007, via FedEx & DHL overnight. Customers were notified this action was being taken to providing notification to their customers as a continued implementation of the Stryker Medical field correction.
The Notification letter instructed their customers to:
1. Locate the gurneys with the serial numbers listed in this advisory.
2. If any of the affected gurneys cannot be located, determine if they have been sold, transferred, or donated to another facility and notify us regarding their new location.
3. Verify the brakes are working properly. The brake function may be checked by engaging the brake pedal and pushing on each end of the gurney to make sure that casters are locked securely.
4. Remove the gurneys with non-functioning brakes from service until brake cams have been replaced and brakes are fully functional.
5. Contract Sechrist for the replacement parts package.
6. Complete the retrofit of the Gurney.
7. Verify correct function of the brake assembly following retrofit.
8. Complete and send the Correction Verification Form contained in the package to Sechrist.
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.
Notas adicionales en la data
Stretcher - Product Code FPO
Causa
Brake problems: the stretcher brake cams may crack while attempting to lock the stretcher brake (sechrist is supplied the stretchers by the manufacturer stryker medical).
Acción
Urgent Medical Device Correction letters were sent to customers beginning on November 9, 2007, via FedEx & DHL overnight. Customers were notified this action was being taken to providing notification to their customers as a continued implementation of the Stryker Medical field correction.
The Notification letter instructed their customers to:
1. Locate the gurneys with the serial numbers listed in this advisory.
2. If any of the affected gurneys cannot be located, determine if they have been sold, transferred, or donated to another facility and notify us regarding their new location.
3. Verify the brakes are working properly. The brake function may be checked by engaging the brake pedal and pushing on each end of the gurney to make sure that casters are locked securely.
4. Remove the gurneys with non-functioning brakes from service until brake cams have been replaced and brakes are fully functional.
5. Contract Sechrist for the replacement parts package.
6. Complete the retrofit of the Gurney.
7. Verify correct function of the brake assembly following retrofit.
8. Complete and send the Correction Verification Form contained in the package to Sechrist.
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.
Notas adicionales en la data
Bracket adhesive resin and tooth conditioner - Product Code DYH
Causa
Mislabeled: product mislabeled with incorrect expiration date. expiration date labeled as 2010/07 instead of 2009/07.
Acción
Ormco sent fourteen (14) consignees Urgent Device Recall Notification via U.S. First Class mail on October 31, 2007. There were two (2) additional letters sent to the consignees in France that were translated into French. The consignees were instructed to complete the Return Form and return any affected product in their inventory. Periodic effectiveness checks will be conducted in order to follow up with non-responders. For more information, contact firm at 1-800-854-1741.
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.
Notas adicionales en la data
cpk or isoenzymes nad reduction - Product Code CGS
Causa
Three potential issues with creatine kinase lot number: 52044hw00: (1) decrease in quality control and/or patient results (2) an iincreased imprecision, or (3) error code 1054 (unable to calculate results, reaction failure) on architect csystems.
Acción
On October 12, 2007, A Product Recall letter was provided to all Clinical Chemistry Creatine Kinase Reagent customers that have received lot number 52044HW00 . Customer reply form were included in all US customers letter. The letter instructed customers to discontinue use of the kits and destroy them following their laboratory procedure, and document the number of kits discarded. Abbott will provide reimbursement for destroyed kits.
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.
Notas adicionales en la data
Implanted spinal-cord stimulator for pain relief - Product Code LGW
Causa
Incorrect data -- corruption of internal memory component results in an inability for the physician to reprogram the ipg with firmware version prior to revision 3.02. when this occurs, the ipg will report an error code of "10h0" or "00h0" through the remote control. under this condition, the ipg will cease to log in some data that could be used for informational purposes. ** it should be noted t.
Acción
Advanced Bionics sent an Important Notification letter on October 5, 2007, via FED-Ex or US Postal Service Certified mail. (International notification activity is in progress.) The recall letter advises that the firm has become aware of an issue with Precision Implantable Pulse Generators (IPG model numbers SC-1100, Sc1110, and ONS-1110) manufactured prior to July 2007. The letter describes the issue in detail. The firm is requesting that customer immediately locate the affected IPGs and set them aside so that they are not used. A Boston Scientific/Advanced Bionics sales representative will contact your facility to confirm these IPGs and arrange for the exchange of these devices.
The firm enclosed Reply Verification Tracking Form listing the IPGs that are at your Clinic according to the firm's records. In addition, the firm recommends that if error code 10h0 or 00h0 is encountered in Implanted IPGs, it may be corrected by upgrading to a newer version of IPG firmware (software that runs in the IPG). The new version of firmware corrects this condition and helps prevent it from occurring in the future. This firmware upgrade is performed non-invasively, through wireless RF telemetry.
If any of patients encounter error code "10h0" or "00h0" on their Remote Control, consignees are advised to contact their Advanced Bionics representative or Technical Services team at (866) 566-8913 to help identify whether the condition can be corrected through a firmware upgrade and, if so, they will help arrange for the upgrade. Please note that some devices may not be upgradeable. The firm request that all consignees return the notification acknowledgement form is included with the letter.
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.
Notas adicionales en la data
Meningitidis Antisera - Product Code GTJ
Causa
Exhibits cross reactivity with neisseria meningitides group w135.
Acción
BD Diagnostics sent an Urgent Product Recall letter, dated September 2007, to all accounts, requesting the discontinue of distribution and that any remaining inventory of the recalled product be discarded. BD will issue credit or send replacement. A receipt of notification needs to be completed and sent back whether or not customers have any remaining inventory. Also, a customer list of end-users who were shipped this product needs to be provided so that the firm may inform them of the issue.
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.
Notas adicionales en la data
Meningitidis Antisera - Product Code GTJ
Causa
Exhibits cross reactivity with neisseria meningitides group w135.
Acción
BD Diagnostics sent an Urgent Product Recall letter, dated September 2007, to all accounts, requesting the discontinue of distribution and that any remaining inventory of the recalled product be discarded. BD will issue credit or send replacement. A receipt of notification needs to be completed and sent back whether or not customers have any remaining inventory. Also, a customer list of end-users who were shipped this product needs to be provided so that the firm may inform them of the issue.
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.
Notas adicionales en la data
Meningitidis Antisera - Product Code GTJ
Causa
Exhibits cross reactivity with neisseria meningitides group w135.
Acción
BD Diagnostics sent an Urgent Product Recall letter, dated September 2007, to all accounts, requesting the discontinue of distribution and that any remaining inventory of the recalled product be discarded. BD will issue credit or send replacement. A receipt of notification needs to be completed and sent back whether or not customers have any remaining inventory. Also, a customer list of end-users who were shipped this product needs to be provided so that the firm may inform them of the issue.
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.
Notas adicionales en la data
Meningitidis Antisera - Product Code GTJ
Causa
Exhibits cross reactivity with neisseria meningitides group w135.
Acción
BD Diagnostics sent an Urgent Product Recall letter, dated September 2007, to all accounts, requesting the discontinue of distribution and that any remaining inventory of the recalled product be discarded. BD will issue credit or send replacement. A receipt of notification needs to be completed and sent back whether or not customers have any remaining inventory. Also, a customer list of end-users who were shipped this product needs to be provided so that the firm may inform them of the issue.