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.
Products were shipped labeled with "use by" dates that exceed currently available shelf-life data. all products remain within the earliest expiration date of april 2015.
Acción
Stryker Neurovascular sent an Urgent Medical Device Recall letter dated November 4, 2013, all affected users. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately discontinue use and segregate the affected products. Customers with questions were instructed to contact via NeuroComplaints@stryker.com. Or Fax the response form to 1-800-876-4355.
For questions regarding this recall call 510-413-2500.
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.
Products were shipped labeled with "use by" dates that exceed currently available shelf-life data. all products remain within the earliest expiration date of april 2015.
Acción
Stryker Neurovascular sent an Urgent Medical Device Recall letter dated November 4, 2013, all affected users. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately discontinue use and segregate the affected products. Customers with questions were instructed to contact via NeuroComplaints@stryker.com. Or Fax the response form to 1-800-876-4355.
For questions regarding this recall call 510-413-2500.
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.
Products were shipped labeled with "use by" dates that exceed currently available shelf-life data. all products remain within the earliest expiration date of april 2015.
Acción
Stryker Neurovascular sent an Urgent Medical Device Recall letter dated November 4, 2013, all affected users. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately discontinue use and segregate the affected products. Customers with questions were instructed to contact via NeuroComplaints@stryker.com. Or Fax the response form to 1-800-876-4355.
For questions regarding this recall call 510-413-2500.
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.
Products were shipped labeled with "use by" dates that exceed currently available shelf-life data. all products remain within the earliest expiration date of april 2015.
Acción
Stryker Neurovascular sent an Urgent Medical Device Recall letter dated November 4, 2013, all affected users. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately discontinue use and segregate the affected products. Customers with questions were instructed to contact via NeuroComplaints@stryker.com. Or Fax the response form to 1-800-876-4355.
For questions regarding this recall call 510-413-2500.
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.
Products were shipped labeled with "use by" dates that exceed currently available shelf-life data. all products remain within the earliest expiration date of april 2015.
Acción
Stryker Neurovascular sent an Urgent Medical Device Recall letter dated November 4, 2013, all affected users. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately discontinue use and segregate the affected products. Customers with questions were instructed to contact via NeuroComplaints@stryker.com. Or Fax the response form to 1-800-876-4355.
For questions regarding this recall call 510-413-2500.
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.
Products were shipped labeled with "use by" dates that exceed currently available shelf-life data. all products remain within the earliest expiration date of april 2015.
Acción
Stryker Neurovascular sent an Urgent Medical Device Recall letter dated November 4, 2013, all affected users. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately discontinue use and segregate the affected products. Customers with questions were instructed to contact via NeuroComplaints@stryker.com. Or Fax the response form to 1-800-876-4355.
For questions regarding this recall call 510-413-2500.
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.
Products were shipped labeled with "use by" dates that exceed currently available shelf-life data. all products remain within the earliest expiration date of april 2015.
Acción
Stryker Neurovascular sent an Urgent Medical Device Recall letter dated November 4, 2013, all affected users. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately discontinue use and segregate the affected products. Customers with questions were instructed to contact via NeuroComplaints@stryker.com. Or Fax the response form to 1-800-876-4355.
For questions regarding this recall call 510-413-2500.
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
wound therapy system - Product Code OMP
Causa
Modification of the bacterial overflow guard (filter) and related changes to product labeling.
Acción
The correction strategy is as follows:
" An Urgent Medical Device Correction Notice has been prepared to be distributed to all US consignees via Federal Express delivery for confirmation of the delivery.
" A copy of the Urgent Medical Device Correction Notice is to be posted on Smith & Nephew's websites, URL corporate, http://www.smith-nephew.com/news-and-media/, and myrenasys.com, concurrent with the distribution of the Notice to consignees.
" US distribution of the original design of Canister Kits codes (66800912, 66800913, 66801066, 66800423 and 66800058) subject to this correction ceased November 1, 2013.
" The correction has been implemented on a change being affected basis. The modified design is being distributed to US customers effective November 1, 2013. No product will be removed from the market.
" Periodic progress reports to FDA, as required per 21 CFR 806 will be submitted monthly until completion of the correction actions..
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
wound therapy system - Product Code OMP
Causa
Modification of the bacterial overflow guard (filter) and related changes to product labeling.
Acción
The correction strategy is as follows:
" An Urgent Medical Device Correction Notice has been prepared to be distributed to all US consignees via Federal Express delivery for confirmation of the delivery.
" A copy of the Urgent Medical Device Correction Notice is to be posted on Smith & Nephew's websites, URL corporate, http://www.smith-nephew.com/news-and-media/, and myrenasys.com, concurrent with the distribution of the Notice to consignees.
" US distribution of the original design of Canister Kits codes (66800912, 66800913, 66801066, 66800423 and 66800058) subject to this correction ceased November 1, 2013.
" The correction has been implemented on a change being affected basis. The modified design is being distributed to US customers effective November 1, 2013. No product will be removed from the market.
" Periodic progress reports to FDA, as required per 21 CFR 806 will be submitted monthly until completion of the correction actions..
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.
Instrumentation Laboratory issued Important Correction Notice via USPS to US customers dated November 2013 advising users in the US that unassayed controls are not acceptable for use in their unassayed (non-value assigned) format. IL will no longer sell or distribute controls without assayed values for the US market as of November 15, 2013, and are converting US customers to an assayed control format. Additional contact with customers via phone calls and a reminder email.
An enclosed response tracking form provided to be returned.
For technical questions, contact the IL Technical Support Center at 1-800-678-0710, Option # 6 (ACL Coagulation Products).
For replacement product if value assignments are not available for your product lot, please contact your IL Customer Service Representative at 1-800-955-9525, Option # 6.
For questions regarding this recall call 781-861-4467.
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.
Instrumentation Laboratory issued Important Correction Notice via USPS to US customers dated November 2013 advising users in the US that unassayed controls are not acceptable for use in their unassayed (non-value assigned) format. IL will no longer sell or distribute controls without assayed values for the US market as of November 15, 2013, and are converting US customers to an assayed control format. Additional contact with customers via phone calls and a reminder email.
An enclosed response tracking form provided to be returned.
For technical questions, contact the IL Technical Support Center at 1-800-678-0710, Option # 6 (ACL Coagulation Products).
For replacement product if value assignments are not available for your product lot, please contact your IL Customer Service Representative at 1-800-955-9525, Option # 6.
For questions regarding this recall call 781-861-4467.
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.
Instrumentation Laboratory issued Important Correction Notice via USPS to US customers dated November 2013 advising users in the US that unassayed controls are not acceptable for use in their unassayed (non-value assigned) format. IL will no longer sell or distribute controls without assayed values for the US market as of November 15, 2013, and are converting US customers to an assayed control format. Additional contact with customers via phone calls and a reminder email.
An enclosed response tracking form provided to be returned.
For technical questions, contact the IL Technical Support Center at 1-800-678-0710, Option # 6 (ACL Coagulation Products).
For replacement product if value assignments are not available for your product lot, please contact your IL Customer Service Representative at 1-800-955-9525, Option # 6.
For questions regarding this recall call 781-861-4467.
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
Wheelchair, mechanical - Product Code IOR
Causa
There is a remote possibility for the plastic latch to deform over the lifetime of use. when this happens there is the possibility for the seat to become dislodged from the base. and when not using the positioning strap, there is a risk that the occupant could slide out of the seat and sustain injury.
Acción
Urgent Medical Device Field correction letters were sent to Sunrise Suppliers/Dealers and Zippie Customers on November 2013 by first class mail. Foreign notification was supplied to suppliers and regulatory affairs director in Canada.
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 of the infusion tubing disconnecting from the connector, resulting in leakage of insulin from the infusion set and providing patient with less insulin than intended.
Acción
Asante sent urgent medical device recall notifications letters to distributors and customers on November 19, 2013 by US mail, return receipt requested.
Cuban data is current through 2018. All of the data comes from the Health Ministry of Cuba, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Cuba.
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, fixation, bone - Product Code HRS
Causa
Based on a review of historic packaging validations, it was determined that a subset of product packaged at a zimmer facility required testing to ensure that previously packaged product from this facility met the established requirements for sterile barrier integrity. this testing determined that a packaging tray configuration which consists of an inner and outer sterile tray, resulted in failure.
Acción
On 11/5/2013, Urgent Medical Device Recall Notifications were sent to affected distributors, hospital Risk Managers, and doctors informing them of the failure.
All distributors were notified via electronic mail. Hospital risk managers, surgeons and distributors with affected inventory within the expiration date of the device will also be notified via courier. The letter identifies the issue, health risks, and their responsibilities. Questions concerning the recall are directed to 1-877-946-2761
Communications outside of the United States will occur approximately two weeks after the United States communications.
Zimmer will conduct effectiveness checks in the following way:
Distributors/Hospitals/Surgeons
100% of the notifications will be tracked to ensure delivery of the notifications.
An inventory certification form will need to be returned from each distributor that certifies that all available affected product from their territory has been returned.
Additional notifications via email and FedEx will be sent to those who have not completed the required certification form or returned affected product.
Accounts will be deemed unresponsive after 3 attempts.
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
Rod, fixation, intramedullary and accessories - Product Code HSB
Causa
Based on a review of historic packaging validations, it was determined that a subset of product packaged at a zimmer facility required testing to ensure that previously packaged product from this facility met the established requirements for sterile barrier integrity. this testing determined that a packaging tray configuration which consists of an inner and outer sterile tray, resulted in failure.
Acción
On 11/5/2013, Urgent Medical Device Recall Notifications were sent to affected distributors, hospital Risk Managers, and doctors informing them of the failure.
All distributors were notified via electronic mail. Hospital risk managers, surgeons and distributors with affected inventory within the expiration date of the device will also be notified via courier. The letter identifies the issue, health risks, and their responsibilities. Questions concerning the recall are directed to 1-877-946-2761
Communications outside of the United States will occur approximately two weeks after the United States communications.
Zimmer will conduct effectiveness checks in the following way:
Distributors/Hospitals/Surgeons
100% of the notifications will be tracked to ensure delivery of the notifications.
An inventory certification form will need to be returned from each distributor that certifies that all available affected product from their territory has been returned.
Additional notifications via email and FedEx will be sent to those who have not completed the required certification form or returned affected product.
Accounts will be deemed unresponsive after 3 attempts.
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
Circuit, breathing (w connector, adaptor, y piece) - Product Code CAI
Causa
Some packages of the rtc 25-c may have been shipped to customers with incomplete installation and usage directions due to a printing error.
Acción
A recall notification letter, dated November 13, 2013, was sent to Users.
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
Lens, contact, (disposable) - Product Code MVN
Causa
Lots were labeled with incorrect expiration dates on secondary package (carton). the primary package (blister) is marked with the correct expiration date.
Acción
CooperVision sent an Urgent Medical Device Recall Letters dated November 20, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers.
Our records indicate you received some of the affected product. Enclosed you will find a list of affected carton lot numbers, with the correct expiration date, that were shipped to your account.
" Please immediately examine your inventory,
" Stop any further distribution of carton(s) subject to the recall,
" Quarantine carton(s) with incorrect expiration date, and
" CooperVision will make arrangements to remove affected, quarantine product.
As soon as possible, please complete the attached response form and fax it to 1.866.484.1048 or scan and email to info@coopervision.com. If you have product to return please contact customer service for instructions and to schedule pick-up and removal of affected, quarantined product. Your account will be credited once the product is returned and processed.
We appreciate your assistance and apologize for any inconvenience you or your patients experienced by this removal. If you have any further questions, please feel free to contact us at 800-341-2020.
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
The access 2 immunoassay system analyzer and the unicel dxi 600 access may have been manufactured with non-conforming bushings. non-conforming bushings have a remote probability of generating incorrect results.
Acción
Beckman Coulter initiated this recall by sending recall notifications to customers. An Urgent Product Correction letter sent to affected customers. The recall letter dated November 22, 2013 informed customer of the recall, products with description and codes, issue, impact, action, resolution, and contact information.
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
Lens, contact, (disposable) - Product Code MVN
Causa
Lots were labeled with incorrect expiration dates on secondary package (carton). the primary package (blister) is marked with the correct expiration date.
Acción
CooperVision sent an Urgent Medical Device Recall Letters dated November 20, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers.
Our records indicate you received some of the affected product. Enclosed you will find a list of affected carton lot numbers, with the correct expiration date, that were shipped to your account.
" Please immediately examine your inventory,
" Stop any further distribution of carton(s) subject to the recall,
" Quarantine carton(s) with incorrect expiration date, and
" CooperVision will make arrangements to remove affected, quarantine product.
As soon as possible, please complete the attached response form and fax it to 1.866.484.1048 or scan and email to info@coopervision.com. If you have product to return please contact customer service for instructions and to schedule pick-up and removal of affected, quarantined product. Your account will be credited once the product is returned and processed.
We appreciate your assistance and apologize for any inconvenience you or your patients experienced by this removal. If you have any further questions, please feel free to contact us at 800-341-2020.
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
Snare, non-electrical - Product Code FGX
Causa
Sterility of device may be compromised due to lack of pouch seal integrity.
Acción
Boston Scientific issued Customer Notification letters to US accounts via Federal Express Priority mail on November 20, 2013. The notification instructs the account to check their inventory, remove any affected product from their inventory, and return it to Boston Scientific. The notification also requests the completion of a Reply Verification Tracking Form.
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
Snare, non-electrical - Product Code FGX
Causa
Sterility of device may be compromised due to lack of pouch seal integrity.
Acción
Boston Scientific issued Customer Notification letters to US accounts via Federal Express Priority mail on November 20, 2013. The notification instructs the account to check their inventory, remove any affected product from their inventory, and return it to Boston Scientific. The notification also requests the completion of a Reply Verification Tracking Form.
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
Snare, non-electrical - Product Code FGX
Causa
Sterility of device may be compromised due to lack of pouch seal integrity.
Acción
Boston Scientific issued Customer Notification letters to US accounts via Federal Express Priority mail on November 20, 2013. The notification instructs the account to check their inventory, remove any affected product from their inventory, and return it to Boston Scientific. The notification also requests the completion of a Reply Verification Tracking Form.
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
Snare, non-electrical - Product Code FGX
Causa
Sterility of device may be compromised due to lack of pouch seal integrity.
Acción
Boston Scientific issued Customer Notification letters to US accounts via Federal Express Priority mail on November 20, 2013. The notification instructs the account to check their inventory, remove any affected product from their inventory, and return it to Boston Scientific. The notification also requests the completion of a Reply Verification Tracking Form.