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
Knife, ophthalmic - Product Code HNN
Causa
The complaints database was reviewed and there have been an atypical volume of dull blades complaints for various lots. out of an abundance of precaution, bausch + lomb is voluntarily recalling all product codes sku manufacturing without the electro-polish control and penetration force testing.
Acción
On March 3, 2017 Bausch + Lomb , distributed Urgent Medical Device Recall notices and Acknowledgement Forms to customers via FedEx. Customers were advised to:
1. Please review your inventory and quarantine all unused (full and partial) boxes of LaserEdge" knives (6/Box or individual packaged knives) affected lots.
2. Complete the enclosed Medical Device Voluntary Recall Acknowledgement Form and contact Bausch + Lomb to obtain a Return Material Authorization Number (RMA) and arrange for a pickup of the identified product. You can contact the Bausch + Lomb Surgical Customer Service team by calling 1-800-338-2020, Customer Service (option 2), Product Returns and Adverse Event Reporting (option 2).
Please contact the Bausch + Lomb Surgical Customer Service team with any questions or concerns regarding this process: 1-800-338-2020.
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
Knife, ophthalmic - Product Code HNN
Causa
The complaints database was reviewed and there have been an atypical volume of dull blades complaints for various lots. out of an abundance of precaution, bausch + lomb is voluntarily recalling all product codes sku manufacturing without the electro-polish control and penetration force testing.
Acción
On March 3, 2017 Bausch + Lomb , distributed Urgent Medical Device Recall notices and Acknowledgement Forms to customers via FedEx. Customers were advised to:
1. Please review your inventory and quarantine all unused (full and partial) boxes of LaserEdge" knives (6/Box or individual packaged knives) affected lots.
2. Complete the enclosed Medical Device Voluntary Recall Acknowledgement Form and contact Bausch + Lomb to obtain a Return Material Authorization Number (RMA) and arrange for a pickup of the identified product. You can contact the Bausch + Lomb Surgical Customer Service team by calling 1-800-338-2020, Customer Service (option 2), Product Returns and Adverse Event Reporting (option 2).
Please contact the Bausch + Lomb Surgical Customer Service team with any questions or concerns regarding this process: 1-800-338-2020.
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
Knife, ophthalmic - Product Code HNN
Causa
The complaints database was reviewed and there have been an atypical volume of dull blades complaints for various lots. out of an abundance of precaution, bausch + lomb is voluntarily recalling all product codes sku manufacturing without the electro-polish control and penetration force testing.
Acción
On March 3, 2017 Bausch + Lomb , distributed Urgent Medical Device Recall notices and Acknowledgement Forms to customers via FedEx. Customers were advised to:
1. Please review your inventory and quarantine all unused (full and partial) boxes of LaserEdge" knives (6/Box or individual packaged knives) affected lots.
2. Complete the enclosed Medical Device Voluntary Recall Acknowledgement Form and contact Bausch + Lomb to obtain a Return Material Authorization Number (RMA) and arrange for a pickup of the identified product. You can contact the Bausch + Lomb Surgical Customer Service team by calling 1-800-338-2020, Customer Service (option 2), Product Returns and Adverse Event Reporting (option 2).
Please contact the Bausch + Lomb Surgical Customer Service team with any questions or concerns regarding this process: 1-800-338-2020.
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
Knife, ophthalmic - Product Code HNN
Causa
The complaints database was reviewed and there have been an atypical volume of dull blades complaints for various lots. out of an abundance of precaution, bausch + lomb is voluntarily recalling all product codes sku manufacturing without the electro-polish control and penetration force testing.
Acción
On March 3, 2017 Bausch + Lomb , distributed Urgent Medical Device Recall notices and Acknowledgement Forms to customers via FedEx. Customers were advised to:
1. Please review your inventory and quarantine all unused (full and partial) boxes of LaserEdge" knives (6/Box or individual packaged knives) affected lots.
2. Complete the enclosed Medical Device Voluntary Recall Acknowledgement Form and contact Bausch + Lomb to obtain a Return Material Authorization Number (RMA) and arrange for a pickup of the identified product. You can contact the Bausch + Lomb Surgical Customer Service team by calling 1-800-338-2020, Customer Service (option 2), Product Returns and Adverse Event Reporting (option 2).
Please contact the Bausch + Lomb Surgical Customer Service team with any questions or concerns regarding this process: 1-800-338-2020.
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
Catheter,intravascular,therapeutic,long-term greater than 30 days - Product Code LJS
Causa
Navilyst medical, inc. (nmi) the manufacturer of the xcela picc with pasv, bioflo picc with pasv and the bioflo picc, conducted this recall to the end user level based on information received from greatbatch medical, the manufacturer of the viapeel ptfe peelable introducer. greatbatch medical determined that the products listed in their 11/11/2016 recall notification have the potential for the handles to detach from the sheath during use. nmi has confirmed that the affected sheaths, greatbatch model number 10890-006, had been included in packaged xcela and bioflo picc kits.
Acción
The firm, Navilyst Medical, sent an "URGENT VOLUNTARY MEDICAL DEVICE RECALL IMMEDIATE ACTION REQUIRED" letter dated 11/28/2016 by issuing recall notifications to consignees via Federal Express. The letter described the product, problems and actions to be taken. The Consignees were instructed to
1. IMMEDIATELY
o Stop using the product subject to recall.
o Remove any affected (recalled) product from your inventory (whether in labs,
Central Supply, Shipping and Receiving or ANY other location).
o Segregate this product in a secure location for return to Navilyst Medical, Inc. (an AngioDynamics Company)
o Forward a copy of this recall notification to all sites to which you have distributed affected product.
2. Complete and return the Reply Verification Tracking Form.
o If affected product is located in your institution, please call AngioDynamics Customer Service at 1-800-772-6446 between 8:00 a.m. and 7:00 p.m. (Monday Friday: Eastern Standard Time) to obtain a replacement or credit for your returned product.
o Promptly complete, sign and return the enclosed Reply Verification Tracking Form (even if you do not have any product to return); following the directions on this page and the Reply Verification Tracking Form.
o Email Reply Verification Tracking Form (preferred): recall@angiodynamics.com
o Fax Reply Verification Tracking Form: Attn: ViaPeel Recall Coordinator
Fax number 1-800-782-1357
3. Package and Return the Recalled Product to: AngioDynamics, Inc.
603 Queensbury Avenue, Queensbury, NY 12804, Attn: ViaPeel Recall Coordinator and complete and return the Reply Verification Tracking Form, provided in the recall notification. Attn: ViaPeel Recall Coordinator.
If you have any questions, please call: 518-795-1358 or 518-795-1116.
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
Catheter,intravascular,therapeutic,long-term greater than 30 days - Product Code LJS
Causa
Navilyst medical, inc. (nmi) the manufacturer of the xcela picc with pasv, bioflo picc with pasv and the bioflo picc, conducted this recall to the end user level based on information received from greatbatch medical, the manufacturer of the viapeel ptfe peelable introducer. greatbatch medical determined that the products listed in their 11/11/2016 recall notification have the potential for the handles to detach from the sheath during use. nmi has confirmed that the affected sheaths, greatbatch model number 10890-006, had been included in packaged xcela and bioflo picc kits.
Acción
The firm, Navilyst Medical, sent an "URGENT VOLUNTARY MEDICAL DEVICE RECALL IMMEDIATE ACTION REQUIRED" letter dated 11/28/2016 by issuing recall notifications to consignees via Federal Express. The letter described the product, problems and actions to be taken. The Consignees were instructed to
1. IMMEDIATELY
o Stop using the product subject to recall.
o Remove any affected (recalled) product from your inventory (whether in labs,
Central Supply, Shipping and Receiving or ANY other location).
o Segregate this product in a secure location for return to Navilyst Medical, Inc. (an AngioDynamics Company)
o Forward a copy of this recall notification to all sites to which you have distributed affected product.
2. Complete and return the Reply Verification Tracking Form.
o If affected product is located in your institution, please call AngioDynamics Customer Service at 1-800-772-6446 between 8:00 a.m. and 7:00 p.m. (Monday Friday: Eastern Standard Time) to obtain a replacement or credit for your returned product.
o Promptly complete, sign and return the enclosed Reply Verification Tracking Form (even if you do not have any product to return); following the directions on this page and the Reply Verification Tracking Form.
o Email Reply Verification Tracking Form (preferred): recall@angiodynamics.com
o Fax Reply Verification Tracking Form: Attn: ViaPeel Recall Coordinator
Fax number 1-800-782-1357
3. Package and Return the Recalled Product to: AngioDynamics, Inc.
603 Queensbury Avenue, Queensbury, NY 12804, Attn: ViaPeel Recall Coordinator and complete and return the Reply Verification Tracking Form, provided in the recall notification. Attn: ViaPeel Recall Coordinator.
If you have any questions, please call: 518-795-1358 or 518-795-1116.
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
Catheter,intravascular,therapeutic,long-term greater than 30 days - Product Code LJS
Causa
Navilyst medical, inc. (nmi) the manufacturer of the xcela picc with pasv, bioflo picc with pasv and the bioflo picc, conducted this recall to the end user level based on information received from greatbatch medical, the manufacturer of the viapeel ptfe peelable introducer. greatbatch medical determined that the products listed in their 11/11/2016 recall notification have the potential for the handles to detach from the sheath during use. nmi has confirmed that the affected sheaths, greatbatch model number 10890-006, had been included in packaged xcela and bioflo picc kits.
Acción
The firm, Navilyst Medical, sent an "URGENT VOLUNTARY MEDICAL DEVICE RECALL IMMEDIATE ACTION REQUIRED" letter dated 11/28/2016 by issuing recall notifications to consignees via Federal Express. The letter described the product, problems and actions to be taken. The Consignees were instructed to
1. IMMEDIATELY
o Stop using the product subject to recall.
o Remove any affected (recalled) product from your inventory (whether in labs,
Central Supply, Shipping and Receiving or ANY other location).
o Segregate this product in a secure location for return to Navilyst Medical, Inc. (an AngioDynamics Company)
o Forward a copy of this recall notification to all sites to which you have distributed affected product.
2. Complete and return the Reply Verification Tracking Form.
o If affected product is located in your institution, please call AngioDynamics Customer Service at 1-800-772-6446 between 8:00 a.m. and 7:00 p.m. (Monday Friday: Eastern Standard Time) to obtain a replacement or credit for your returned product.
o Promptly complete, sign and return the enclosed Reply Verification Tracking Form (even if you do not have any product to return); following the directions on this page and the Reply Verification Tracking Form.
o Email Reply Verification Tracking Form (preferred): recall@angiodynamics.com
o Fax Reply Verification Tracking Form: Attn: ViaPeel Recall Coordinator
Fax number 1-800-782-1357
3. Package and Return the Recalled Product to: AngioDynamics, Inc.
603 Queensbury Avenue, Queensbury, NY 12804, Attn: ViaPeel Recall Coordinator and complete and return the Reply Verification Tracking Form, provided in the recall notification. Attn: ViaPeel Recall Coordinator.
If you have any questions, please call: 518-795-1358 or 518-795-1116.
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
Catheter,intravascular,therapeutic,long-term greater than 30 days - Product Code LJS
Causa
Navilyst medical, inc. (nmi) the manufacturer of the xcela picc with pasv, bioflo picc with pasv and the bioflo picc, conducted this recall to the end user level based on information received from greatbatch medical, the manufacturer of the viapeel ptfe peelable introducer. greatbatch medical determined that the products listed in their 11/11/2016 recall notification have the potential for the handles to detach from the sheath during use. nmi has confirmed that the affected sheaths, greatbatch model number 10890-006, had been included in packaged xcela and bioflo picc kits.
Acción
The firm, Navilyst Medical, sent an "URGENT VOLUNTARY MEDICAL DEVICE RECALL IMMEDIATE ACTION REQUIRED" letter dated 11/28/2016 by issuing recall notifications to consignees via Federal Express. The letter described the product, problems and actions to be taken. The Consignees were instructed to
1. IMMEDIATELY
o Stop using the product subject to recall.
o Remove any affected (recalled) product from your inventory (whether in labs,
Central Supply, Shipping and Receiving or ANY other location).
o Segregate this product in a secure location for return to Navilyst Medical, Inc. (an AngioDynamics Company)
o Forward a copy of this recall notification to all sites to which you have distributed affected product.
2. Complete and return the Reply Verification Tracking Form.
o If affected product is located in your institution, please call AngioDynamics Customer Service at 1-800-772-6446 between 8:00 a.m. and 7:00 p.m. (Monday Friday: Eastern Standard Time) to obtain a replacement or credit for your returned product.
o Promptly complete, sign and return the enclosed Reply Verification Tracking Form (even if you do not have any product to return); following the directions on this page and the Reply Verification Tracking Form.
o Email Reply Verification Tracking Form (preferred): recall@angiodynamics.com
o Fax Reply Verification Tracking Form: Attn: ViaPeel Recall Coordinator
Fax number 1-800-782-1357
3. Package and Return the Recalled Product to: AngioDynamics, Inc.
603 Queensbury Avenue, Queensbury, NY 12804, Attn: ViaPeel Recall Coordinator and complete and return the Reply Verification Tracking Form, provided in the recall notification. Attn: ViaPeel Recall Coordinator.
If you have any questions, please call: 518-795-1358 or 518-795-1116.
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
Catheter,intravascular,therapeutic,long-term greater than 30 days - Product Code LJS
Causa
Navilyst medical, inc. (nmi) the manufacturer of the xcela picc with pasv, bioflo picc with pasv and the bioflo picc, conducted this recall to the end user level based on information received from greatbatch medical, the manufacturer of the viapeel ptfe peelable introducer. greatbatch medical determined that the products listed in their 11/11/2016 recall notification have the potential for the handles to detach from the sheath during use. nmi has confirmed that the affected sheaths, greatbatch model number 10890-006, had been included in packaged xcela and bioflo picc kits.
Acción
The firm, Navilyst Medical, sent an "URGENT VOLUNTARY MEDICAL DEVICE RECALL IMMEDIATE ACTION REQUIRED" letter dated 11/28/2016 by issuing recall notifications to consignees via Federal Express. The letter described the product, problems and actions to be taken. The Consignees were instructed to
1. IMMEDIATELY
o Stop using the product subject to recall.
o Remove any affected (recalled) product from your inventory (whether in labs,
Central Supply, Shipping and Receiving or ANY other location).
o Segregate this product in a secure location for return to Navilyst Medical, Inc. (an AngioDynamics Company)
o Forward a copy of this recall notification to all sites to which you have distributed affected product.
2. Complete and return the Reply Verification Tracking Form.
o If affected product is located in your institution, please call AngioDynamics Customer Service at 1-800-772-6446 between 8:00 a.m. and 7:00 p.m. (Monday Friday: Eastern Standard Time) to obtain a replacement or credit for your returned product.
o Promptly complete, sign and return the enclosed Reply Verification Tracking Form (even if you do not have any product to return); following the directions on this page and the Reply Verification Tracking Form.
o Email Reply Verification Tracking Form (preferred): recall@angiodynamics.com
o Fax Reply Verification Tracking Form: Attn: ViaPeel Recall Coordinator
Fax number 1-800-782-1357
3. Package and Return the Recalled Product to: AngioDynamics, Inc.
603 Queensbury Avenue, Queensbury, NY 12804, Attn: ViaPeel Recall Coordinator and complete and return the Reply Verification Tracking Form, provided in the recall notification. Attn: ViaPeel Recall Coordinator.
If you have any questions, please call: 518-795-1358 or 518-795-1116.
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
Catheter,intravascular,therapeutic,long-term greater than 30 days - Product Code LJS
Causa
Navilyst medical, inc. (nmi) the manufacturer of the xcela picc with pasv, bioflo picc with pasv and the bioflo picc, conducted this recall to the end user level based on information received from greatbatch medical, the manufacturer of the viapeel ptfe peelable introducer. greatbatch medical determined that the products listed in their 11/11/2016 recall notification have the potential for the handles to detach from the sheath during use. nmi has confirmed that the affected sheaths, greatbatch model number 10890-006, had been included in packaged xcela and bioflo picc kits.
Acción
The firm, Navilyst Medical, sent an "URGENT VOLUNTARY MEDICAL DEVICE RECALL IMMEDIATE ACTION REQUIRED" letter dated 11/28/2016 by issuing recall notifications to consignees via Federal Express. The letter described the product, problems and actions to be taken. The Consignees were instructed to
1. IMMEDIATELY
o Stop using the product subject to recall.
o Remove any affected (recalled) product from your inventory (whether in labs,
Central Supply, Shipping and Receiving or ANY other location).
o Segregate this product in a secure location for return to Navilyst Medical, Inc. (an AngioDynamics Company)
o Forward a copy of this recall notification to all sites to which you have distributed affected product.
2. Complete and return the Reply Verification Tracking Form.
o If affected product is located in your institution, please call AngioDynamics Customer Service at 1-800-772-6446 between 8:00 a.m. and 7:00 p.m. (Monday Friday: Eastern Standard Time) to obtain a replacement or credit for your returned product.
o Promptly complete, sign and return the enclosed Reply Verification Tracking Form (even if you do not have any product to return); following the directions on this page and the Reply Verification Tracking Form.
o Email Reply Verification Tracking Form (preferred): recall@angiodynamics.com
o Fax Reply Verification Tracking Form: Attn: ViaPeel Recall Coordinator
Fax number 1-800-782-1357
3. Package and Return the Recalled Product to: AngioDynamics, Inc.
603 Queensbury Avenue, Queensbury, NY 12804, Attn: ViaPeel Recall Coordinator and complete and return the Reply Verification Tracking Form, provided in the recall notification. Attn: ViaPeel Recall Coordinator.
If you have any questions, please call: 518-795-1358 or 518-795-1116.
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
Catheter,intravascular,therapeutic,long-term greater than 30 days - Product Code LJS
Causa
Navilyst medical, inc. (nmi) the manufacturer of the xcela picc with pasv, bioflo picc with pasv and the bioflo picc, conducted this recall to the end user level based on information received from greatbatch medical, the manufacturer of the viapeel ptfe peelable introducer. greatbatch medical determined that the products listed in their 11/11/2016 recall notification have the potential for the handles to detach from the sheath during use. nmi has confirmed that the affected sheaths, greatbatch model number 10890-006, had been included in packaged xcela and bioflo picc kits.
Acción
The firm, Navilyst Medical, sent an "URGENT VOLUNTARY MEDICAL DEVICE RECALL IMMEDIATE ACTION REQUIRED" letter dated 11/28/2016 by issuing recall notifications to consignees via Federal Express. The letter described the product, problems and actions to be taken. The Consignees were instructed to
1. IMMEDIATELY
o Stop using the product subject to recall.
o Remove any affected (recalled) product from your inventory (whether in labs,
Central Supply, Shipping and Receiving or ANY other location).
o Segregate this product in a secure location for return to Navilyst Medical, Inc. (an AngioDynamics Company)
o Forward a copy of this recall notification to all sites to which you have distributed affected product.
2. Complete and return the Reply Verification Tracking Form.
o If affected product is located in your institution, please call AngioDynamics Customer Service at 1-800-772-6446 between 8:00 a.m. and 7:00 p.m. (Monday Friday: Eastern Standard Time) to obtain a replacement or credit for your returned product.
o Promptly complete, sign and return the enclosed Reply Verification Tracking Form (even if you do not have any product to return); following the directions on this page and the Reply Verification Tracking Form.
o Email Reply Verification Tracking Form (preferred): recall@angiodynamics.com
o Fax Reply Verification Tracking Form: Attn: ViaPeel Recall Coordinator
Fax number 1-800-782-1357
3. Package and Return the Recalled Product to: AngioDynamics, Inc.
603 Queensbury Avenue, Queensbury, NY 12804, Attn: ViaPeel Recall Coordinator and complete and return the Reply Verification Tracking Form, provided in the recall notification. Attn: ViaPeel Recall Coordinator.
If you have any questions, please call: 518-795-1358 or 518-795-1116.
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
Catheter,intravascular,therapeutic,long-term greater than 30 days - Product Code LJS
Causa
Navilyst medical, inc. (nmi) the manufacturer of the xcela picc with pasv, bioflo picc with pasv and the bioflo picc, conducted this recall to the end user level based on information received from greatbatch medical, the manufacturer of the viapeel ptfe peelable introducer. greatbatch medical determined that the products listed in their 11/11/2016 recall notification have the potential for the handles to detach from the sheath during use. nmi has confirmed that the affected sheaths, greatbatch model number 10890-006, had been included in packaged xcela and bioflo picc kits.
Acción
The firm, Navilyst Medical, sent an "URGENT VOLUNTARY MEDICAL DEVICE RECALL IMMEDIATE ACTION REQUIRED" letter dated 11/28/2016 by issuing recall notifications to consignees via Federal Express. The letter described the product, problems and actions to be taken. The Consignees were instructed to
1. IMMEDIATELY
o Stop using the product subject to recall.
o Remove any affected (recalled) product from your inventory (whether in labs,
Central Supply, Shipping and Receiving or ANY other location).
o Segregate this product in a secure location for return to Navilyst Medical, Inc. (an AngioDynamics Company)
o Forward a copy of this recall notification to all sites to which you have distributed affected product.
2. Complete and return the Reply Verification Tracking Form.
o If affected product is located in your institution, please call AngioDynamics Customer Service at 1-800-772-6446 between 8:00 a.m. and 7:00 p.m. (Monday Friday: Eastern Standard Time) to obtain a replacement or credit for your returned product.
o Promptly complete, sign and return the enclosed Reply Verification Tracking Form (even if you do not have any product to return); following the directions on this page and the Reply Verification Tracking Form.
o Email Reply Verification Tracking Form (preferred): recall@angiodynamics.com
o Fax Reply Verification Tracking Form: Attn: ViaPeel Recall Coordinator
Fax number 1-800-782-1357
3. Package and Return the Recalled Product to: AngioDynamics, Inc.
603 Queensbury Avenue, Queensbury, NY 12804, Attn: ViaPeel Recall Coordinator and complete and return the Reply Verification Tracking Form, provided in the recall notification. Attn: ViaPeel Recall Coordinator.
If you have any questions, please call: 518-795-1358 or 518-795-1116.
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
Catheter,intravascular,therapeutic,long-term greater than 30 days - Product Code LJS
Causa
Navilyst medical, inc. (nmi) the manufacturer of the xcela picc with pasv, bioflo picc with pasv and the bioflo picc, conducted this recall to the end user level based on information received from greatbatch medical, the manufacturer of the viapeel ptfe peelable introducer. greatbatch medical determined that the products listed in their 11/11/2016 recall notification have the potential for the handles to detach from the sheath during use. nmi has confirmed that the affected sheaths, greatbatch model number 10890-006, had been included in packaged xcela and bioflo picc kits.
Acción
The firm, Navilyst Medical, sent an "URGENT VOLUNTARY MEDICAL DEVICE RECALL IMMEDIATE ACTION REQUIRED" letter dated 11/28/2016 by issuing recall notifications to consignees via Federal Express. The letter described the product, problems and actions to be taken. The Consignees were instructed to
1. IMMEDIATELY
o Stop using the product subject to recall.
o Remove any affected (recalled) product from your inventory (whether in labs,
Central Supply, Shipping and Receiving or ANY other location).
o Segregate this product in a secure location for return to Navilyst Medical, Inc. (an AngioDynamics Company)
o Forward a copy of this recall notification to all sites to which you have distributed affected product.
2. Complete and return the Reply Verification Tracking Form.
o If affected product is located in your institution, please call AngioDynamics Customer Service at 1-800-772-6446 between 8:00 a.m. and 7:00 p.m. (Monday Friday: Eastern Standard Time) to obtain a replacement or credit for your returned product.
o Promptly complete, sign and return the enclosed Reply Verification Tracking Form (even if you do not have any product to return); following the directions on this page and the Reply Verification Tracking Form.
o Email Reply Verification Tracking Form (preferred): recall@angiodynamics.com
o Fax Reply Verification Tracking Form: Attn: ViaPeel Recall Coordinator
Fax number 1-800-782-1357
3. Package and Return the Recalled Product to: AngioDynamics, Inc.
603 Queensbury Avenue, Queensbury, NY 12804, Attn: ViaPeel Recall Coordinator and complete and return the Reply Verification Tracking Form, provided in the recall notification. Attn: ViaPeel Recall Coordinator.
If you have any questions, please call: 518-795-1358 or 518-795-1116.
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
Some implant vial caps in the recalled implant lot may inadvertently crack as the result of a manufacturing assembly condition.
Acción
Recall notification letters will be sent to distributors and clinicians on or about the last week of November 2017. International distributors will be notified via courier or email. Clinicians will be instructed to; 1. Follow any specified patient monitoring instructions, 2. Return Attachment 1 (Acknowledgment of Responsibility) to Zimmer Biomet, 3. Review their inventory and returning any affected 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.
Manufacturing error in humidification chamber may cause an overfill/overflow condition of the chamber. the may case a water back-up into the patient circuit resulting in an excessive amount of water entering the airway/lungs of the ventilated patient.
Acción
The firm, Vyaire Medical, sent an "URGENT RECALL NOTIFICATION" letter dated November 29th, 2017 to its customers. The recall letter described the product, problem and actions to be taken. The customers were instructed to do the following:
"ALL CUSTOMERS:
~ Inspect current inventory on-hand. A 100% physical inventory should immediately be performed to identify and remove affected lots of the AirLife Humidification Chamber(s) and Heated Breathing Circuit Kit(s) due to the identified potential patient safety risk.
~ Destroy all affected product(s) in-stock in accordance with your facility's destruction protocol.
~ If you are a healthcare facility or distributor that has further distributed affected product you must further notify your customers of this URGENT RECALL NOTIFICATION.
CUSTOMERS THAT HAVE PURCHASED DIRECT FROM VYAIRE:
~ Complete the Customer Response Form (Appendix 2) and return to GMB-GLBALFieldActions@CareFusion.com
~ If you wish to receive credit of your in-stock product affected by this recall or to place an order for the replacement Model/Part Numbers (as referenced per #6. Per the FAQ's) please contact Vyaire Medical's Customer Service Department at 800.323.9088 (Option #1, followed by Option #1) Monday-Friday 8:00 am CST - 5:00 pm CST.
*Please have your original PO number available when calling to expedite the credit process.
CUSTOMERS THAT HAVE PURCHASED THROUGH A DISTRIBUTOR:
~ Please work with your distributor to receive credit of your in-stock product affected by this recall.
For any additional questions and support concerning this voluntary recall, please contact Clinical Risk Coordinator, at 827-757-0109 or lindy.schenning@vyaire.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.
Manufacturing error in humidification chamber may cause an overfill/overflow condition of the chamber. the may case a water back-up into the patient circuit resulting in an excessive amount of water entering the airway/lungs of the ventilated patient.
Acción
The firm, Vyaire Medical, sent an "URGENT RECALL NOTIFICATION" letter dated November 29th, 2017 to its customers. The recall letter described the product, problem and actions to be taken. The customers were instructed to do the following:
"ALL CUSTOMERS:
~ Inspect current inventory on-hand. A 100% physical inventory should immediately be performed to identify and remove affected lots of the AirLife Humidification Chamber(s) and Heated Breathing Circuit Kit(s) due to the identified potential patient safety risk.
~ Destroy all affected product(s) in-stock in accordance with your facility's destruction protocol.
~ If you are a healthcare facility or distributor that has further distributed affected product you must further notify your customers of this URGENT RECALL NOTIFICATION.
CUSTOMERS THAT HAVE PURCHASED DIRECT FROM VYAIRE:
~ Complete the Customer Response Form (Appendix 2) and return to GMB-GLBALFieldActions@CareFusion.com
~ If you wish to receive credit of your in-stock product affected by this recall or to place an order for the replacement Model/Part Numbers (as referenced per #6. Per the FAQ's) please contact Vyaire Medical's Customer Service Department at 800.323.9088 (Option #1, followed by Option #1) Monday-Friday 8:00 am CST - 5:00 pm CST.
*Please have your original PO number available when calling to expedite the credit process.
CUSTOMERS THAT HAVE PURCHASED THROUGH A DISTRIBUTOR:
~ Please work with your distributor to receive credit of your in-stock product affected by this recall.
For any additional questions and support concerning this voluntary recall, please contact Clinical Risk Coordinator, at 827-757-0109 or lindy.schenning@vyaire.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
Sponge, Ophthalmic - Product Code HOZ
Causa
Sterility of the device is compromised.
Acción
Ultracell Medical Technologies initiated the recall by fax or mail on 1/8/03. The firm requested return of product . Distributors were requestd to recall to their accounts.
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
Appliance, fixation, spinal intervertebral body - Product Code KWQ
Causa
Product labeling for tryptik 2-c-plate self tapping screw, ref try-ps 40, lot 3-5934 contains the sketch/drawing of a self-drilling screw.
Acción
Spineart sent an Urgent Medical Device letter by email dated November 27, 2017. The letter stated the following:
"Out of an abundance of caution", we have decided to recall the concerned products.
Please carefully follow instructions detailed below:
1. Immediately examine your inventory and quarantine product subject to recall.
2. In addition, if you may have further distributed this product, please identify your customers and notify them at once of this product recall by using this document.
3. Collect and quarantine all products.
4. Send back all products and the enclosed Response Form to Spineart Geneva E-mail: regulatory@spineart.com."
For further questions, please call (949) 313-6400..
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
Appliance, fixation, spinal intervertebral body - Product Code KWQ
Causa
Product labeling for tryptik 2-c-plate self tapping screw, ref try-ps 40, lot 3-5934 contains the sketch/drawing of a self-drilling screw.
Acción
Spineart sent an Urgent Medical Device letter by email dated November 27, 2017. The letter stated the following:
"Out of an abundance of caution", we have decided to recall the concerned products.
Please carefully follow instructions detailed below:
1. Immediately examine your inventory and quarantine product subject to recall.
2. In addition, if you may have further distributed this product, please identify your customers and notify them at once of this product recall by using this document.
3. Collect and quarantine all products.
4. Send back all products and the enclosed Response Form to Spineart Geneva E-mail: regulatory@spineart.com."
For further questions, please call (949) 313-6400..
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
Appliance, fixation, spinal intervertebral body - Product Code KWQ
Causa
Product labeling for tryptik 2-c-plate self tapping screw, ref try-ps 40, lot 3-5934 contains the sketch/drawing of a self-drilling screw.
Acción
Spineart sent an Urgent Medical Device letter by email dated November 27, 2017. The letter stated the following:
"Out of an abundance of caution", we have decided to recall the concerned products.
Please carefully follow instructions detailed below:
1. Immediately examine your inventory and quarantine product subject to recall.
2. In addition, if you may have further distributed this product, please identify your customers and notify them at once of this product recall by using this document.
3. Collect and quarantine all products.
4. Send back all products and the enclosed Response Form to Spineart Geneva E-mail: regulatory@spineart.com."
For further questions, please call (949) 313-6400..
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
Appliance, fixation, spinal intervertebral body - Product Code KWQ
Causa
Product labeling for tryptik 2-c-plate self tapping screw, ref try-ps 40, lot 3-5934 contains the sketch/drawing of a self-drilling screw.
Acción
Spineart sent an Urgent Medical Device letter by email dated November 27, 2017. The letter stated the following:
"Out of an abundance of caution", we have decided to recall the concerned products.
Please carefully follow instructions detailed below:
1. Immediately examine your inventory and quarantine product subject to recall.
2. In addition, if you may have further distributed this product, please identify your customers and notify them at once of this product recall by using this document.
3. Collect and quarantine all products.
4. Send back all products and the enclosed Response Form to Spineart Geneva E-mail: regulatory@spineart.com."
For further questions, please call (949) 313-6400..
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
Appliance, fixation, spinal intervertebral body - Product Code KWQ
Causa
Product labeling for tryptik 2-c-plate self tapping screw, ref try-ps 40, lot 3-5934 contains the sketch/drawing of a self-drilling screw.
Acción
Spineart sent an Urgent Medical Device letter by email dated November 27, 2017. The letter stated the following:
"Out of an abundance of caution", we have decided to recall the concerned products.
Please carefully follow instructions detailed below:
1. Immediately examine your inventory and quarantine product subject to recall.
2. In addition, if you may have further distributed this product, please identify your customers and notify them at once of this product recall by using this document.
3. Collect and quarantine all products.
4. Send back all products and the enclosed Response Form to Spineart Geneva E-mail: regulatory@spineart.com."
For further questions, please call (949) 313-6400..
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
Appliance, fixation, spinal intervertebral body - Product Code KWQ
Causa
Product labeling for tryptik 2-c-plate self tapping screw, ref try-ps 40, lot 3-5934 contains the sketch/drawing of a self-drilling screw.
Acción
Spineart sent an Urgent Medical Device letter by email dated November 27, 2017. The letter stated the following:
"Out of an abundance of caution", we have decided to recall the concerned products.
Please carefully follow instructions detailed below:
1. Immediately examine your inventory and quarantine product subject to recall.
2. In addition, if you may have further distributed this product, please identify your customers and notify them at once of this product recall by using this document.
3. Collect and quarantine all products.
4. Send back all products and the enclosed Response Form to Spineart Geneva E-mail: regulatory@spineart.com."
For further questions, please call (949) 313-6400..
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
Appliance, fixation, spinal intervertebral body - Product Code KWQ
Causa
Product labeling for tryptik 2-c-plate self tapping screw, ref try-ps 40, lot 3-5934 contains the sketch/drawing of a self-drilling screw.
Acción
Spineart sent an Urgent Medical Device letter by email dated November 27, 2017. The letter stated the following:
"Out of an abundance of caution", we have decided to recall the concerned products.
Please carefully follow instructions detailed below:
1. Immediately examine your inventory and quarantine product subject to recall.
2. In addition, if you may have further distributed this product, please identify your customers and notify them at once of this product recall by using this document.
3. Collect and quarantine all products.
4. Send back all products and the enclosed Response Form to Spineart Geneva E-mail: regulatory@spineart.com."
For further questions, please call (949) 313-6400..
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
System, x-ray, stationary - Product Code KPR
Causa
A potential issue in the x-ray tube ceiling unit ch-200 which constitutes the digital radiography system fdr visionary suite. the x-ray tube assembly in these devices is mounted to a tube mounting flange, which is part of the tube holding shaft. where cracks may occur over time on the tube holding shaft near the base of the tube
mounting flange.
Acción
FUJIFILM Medical Systems U.S. A. Inc. (FMSU) sent "Urgent: Medial Device Correction" recall notification letter dated June 21, 2017 to all Customers. Customers were notified of the recall, potential issue, potential hazard, description of the issue, the actions planned to correct the issue, the actions to be taken by the customer and contact information. A Customer Feedback Form was provided accompanying the letter.
FMSU service personnel will contact all of the medical facilities where the applicable products have been installed to arrange for this correction and visit to take corrective measures. As FMSUs planned field correction at the affected sites, FMSU will install the additional protective parts preventing the X-ray tube assembly from coming into contact with the patient or operator should separation of the tube mounting flange from the tube holding shaft occur.
For further questions, please call (203) 324-2000.