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.
Notas adicionales en la data
Wrench - Product Code HXC
Causa
A component failure could cause a situation where the applied torque was significantly higher than the calibrated torque setting.
Acción
Consignees were sent a Bradshaw Medical "Product Withdrawal Notice" letter, date marked starting February 2, 2015. The letter specified the Part Number, Lot Number (s) and Shipped date for each consignee. The letter described the product and advised consignees to discontinue use of the product. Requested consignees to complete and return the Customer /Distribution verification Form to BMI Regulatory Affairs FAX (262) 925-1380 and to further send the "Withdrawal Notice and Customer Verification Form" to all customers to whom they have distributed the product.
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
Plate, bone - Product Code JEY
Causa
Labeling errors. the outer packge label expiration date may exceed the expiration date of the subcomponents.
Acción
DePuy Synthes sent an Urgent Medical Device Recall Notice dated May 2, 2016, to all affected customers. The notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review their inventory immediately and remove the affected lots from their stock. Customers were instructed to call 1-800-479-6329 to obtain a Return Authorization (RA) Number and replacement product., customers were also asked to complete the Verification Section and scan/email to
Synthes4096@stericycle.com. Customers with questions were instructed to call 610-719-5450.
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
Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
Causa
Discrepant patient results on dimension vista intelligent lab systems. siemens healthcare confirmed a software defect which, in a very specific set of circumstances, results in the dimension vista system omitting an aliquot probe rinse between sample aspirations when processing tubes in sample racks that are front loaded on the dimension vista system.
Acción
Siemens sent an Urgent Medical Device Correction letter dated March 24, 2016, to all affected customers. Customers were advised to follow the instructions contained in the "Urgent Medical Device Correction" notification letter to help minimize or eliminate the impact that this specific software defect could cause until a software correction could be made (i.e instructions to minimize the impact of the software defect due to "Bad Sample Detect " False Transition" errors when processing front loaded samples) and (how to eliminate the impact of the software defect when processing front loaded samples). Customers were also asked to review the recall notification letter with their Medical Director and complete and return the Field Correction Effectiveness Check Form within 30 days. Customers with questions were advised to contact Siemens Customer Care Center - Technical Solutions at 800-441-9250 or their local Siemens technical support representative.
For questions regarding this recall call 302-631-8248.
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
Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
Causa
Discrepant patient results on dimension vista intelligent lab systems. siemens healthcare confirmed a software defect which, in a very specific set of circumstances, results in the dimension vista system omitting an aliquot probe rinse between sample aspirations when processing tubes in sample racks that are front loaded on the dimension vista system.
Acción
Siemens sent an Urgent Medical Device Correction letter dated March 24, 2016, to all affected customers. Customers were advised to follow the instructions contained in the "Urgent Medical Device Correction" notification letter to help minimize or eliminate the impact that this specific software defect could cause until a software correction could be made (i.e instructions to minimize the impact of the software defect due to "Bad Sample Detect " False Transition" errors when processing front loaded samples) and (how to eliminate the impact of the software defect when processing front loaded samples). Customers were also asked to review the recall notification letter with their Medical Director and complete and return the Field Correction Effectiveness Check Form within 30 days. Customers with questions were advised to contact Siemens Customer Care Center - Technical Solutions at 800-441-9250 or their local Siemens technical support representative.
For questions regarding this recall call 302-631-8248.
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.
Software error in previous software versions in which two references for the same image may exist in the database.
Acción
Siemens sent an Customer Information letter dated May 10, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
The letter with software instruction to customers informing them about an upcoming software VB10B under(SY003/16/P) update change and issue that the new software version will address. For further questions, please call (610) 448-6478.
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.
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.
An Urgent Medical Device Recall (UMDR) notice (Customer Letter) was sent to the 35 individual affected customer sites by UPS on May 17 2016.
Customers were asked to take the following actions: " Discontinue use of cobas¿ Liat Influenza A/B Quality Control kit lot numbers 51222E, 60121H, 60201D, and 60229F, and discard them per your local regulations. " Complete the enclosed UMDC faxback form (6941-00-0516) and fax it to 1-844-449-8506. " File this UMDC for future reference.
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.
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.
Notas adicionales en la data
Implant, endosseous, root-form - Product Code DZE
Causa
Pouches may not have been sealed during packing.
Acción
Biomet sent an Urgent Device Recall Notice to all affected consignees the week of November 30, 2015, communicating the issue and customer responsibilities. International consignees were notified via traceable courier or email week of November 30, 2015. Customers were instructed to return affected product by calling BIOMET at 1-800-342-5454 to obtain a RMA number to return products. Customers were also asked to complete the Business Reply Form and fax to 561-514-6316.
For questions regarding this recall call 561-776-6700.
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.
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.
Biomet sent an Urgent Device Recall Notice to all affected consignees the week of November 30, 2015, communicating the issue and customer responsibilities. International consignees were notified via traceable courier or email week of November 30, 2015. Customers were instructed to return affected product by calling BIOMET at 1-800-342-5454 to obtain a RMA number to return products. Customers were also asked to complete the Business Reply Form and fax to 561-514-6316.
For questions regarding this recall call 561-776-6700.
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