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.
Skull pins, which fractured below device specifications during qc testing, were distributed.
Acción
The firm notified their customers of the recall via facsimile on 6/29/2004. The faxed notification was followed by a hard copy of the recall letter sent via overnight mail. The letter instructs the customers to immediate cease using of the affected product; complete the Fax Back form provided with the recall notice; and return the affected product to Integra for replacement.
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
Set, Tubing And Support, Ventilator (W Harness) - Product Code BZO
Causa
The non-rebreathing masks and watertraps were manufactured with natural rubber or rubber by-products and were not labeled appropriately as containinig latex.
Acción
Medex telephoned the direct accounts on 7/12/04, and will fax and mail follow-up recall letters dated 7/2/04 on 7/13/04, informing them that the affected products were manufactured with natural rubber or rubber by-products and were not labeled appropriately as containing latex. The accounts were requested to cease distribution/use of the affected lots and return them to Medex for free replacement. The accounts were asked to contact Customer Service at 1-800-848-1757 to make arrangements for the return and replacement of their affected product. Distributors were requested to sub-recall the products from their customers. Any questions were directed to Terri Davis at 1-800-848-1757, ext. 5542.
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
Set, Tubing And Support, Ventilator (W Harness) - Product Code BZO
Causa
The non-rebreathing masks and watertraps were manufactured with natural rubber or rubber by-products and were not labeled appropriately as containinig latex.
Acción
Medex telephoned the direct accounts on 7/12/04, and will fax and mail follow-up recall letters dated 7/2/04 on 7/13/04, informing them that the affected products were manufactured with natural rubber or rubber by-products and were not labeled appropriately as containing latex. The accounts were requested to cease distribution/use of the affected lots and return them to Medex for free replacement. The accounts were asked to contact Customer Service at 1-800-848-1757 to make arrangements for the return and replacement of their affected product. Distributors were requested to sub-recall the products from their customers. Any questions were directed to Terri Davis at 1-800-848-1757, ext. 5542.
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
Drain, Tee (Water Trap) - Product Code BYH
Causa
The non-rebreathing masks and watertraps were manufactured with natural rubber or rubber by-products and were not labeled appropriately as containinig latex.
Acción
Medex telephoned the direct accounts on 7/12/04, and will fax and mail follow-up recall letters dated 7/2/04 on 7/13/04, informing them that the affected products were manufactured with natural rubber or rubber by-products and were not labeled appropriately as containing latex. The accounts were requested to cease distribution/use of the affected lots and return them to Medex for free replacement. The accounts were asked to contact Customer Service at 1-800-848-1757 to make arrangements for the return and replacement of their affected product. Distributors were requested to sub-recall the products from their customers. Any questions were directed to Terri Davis at 1-800-848-1757, ext. 5542.
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.
Introducer tubing may contain a vein of unextruded material and carbon black or a strand of tubing material may be displaced from the introducer during use.
Acción
The firm issued recall letters to customers on 6/10/04. The recall was extended and URGENT EXTENSION OF PRODUCT RECALL notices were sent out on June 23, 2004.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Drain, Tee (Water Trap) - Product Code BYH
Causa
The non-rebreathing masks and watertraps were manufactured with natural rubber or rubber by-products and were not labeled appropriately as containinig latex.
Acción
Medex telephoned the direct accounts on 7/12/04, and will fax and mail follow-up recall letters dated 7/2/04 on 7/13/04, informing them that the affected products were manufactured with natural rubber or rubber by-products and were not labeled appropriately as containing latex. The accounts were requested to cease distribution/use of the affected lots and return them to Medex for free replacement. The accounts were asked to contact Customer Service at 1-800-848-1757 to make arrangements for the return and replacement of their affected product. Distributors were requested to sub-recall the products from their customers. Any questions were directed to Terri Davis at 1-800-848-1757, ext. 5542.
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.
Introducer tubing may contain a vein of unextruded material and carbon black or a strand of tubing material may be displaced from the introducer during use.
Acción
The firm issued recall letters to customers on 6/10/04. The recall was extended and URGENT EXTENSION OF PRODUCT RECALL notices were sent out on June 23, 2004.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Introducer tubing may contain a vein of unextruded material and carbon black or a strand of tubing material may be displaced from the introducer during use.
Acción
The firm issued recall letters to customers on 6/10/04. The recall was extended and URGENT EXTENSION OF PRODUCT RECALL notices were sent out on June 23, 2004.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Introducer tubing may contain a vein of unextruded material and carbon black or a strand of tubing material may be displaced from the introducer during use.
Acción
The firm issued recall letters to customers on 6/10/04. The recall was extended and URGENT EXTENSION OF PRODUCT RECALL notices were sent out on June 23, 2004.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Introducer tubing may contain a vein of unextruded material and carbon black or a strand of tubing material may be displaced from the introducer during use.
Acción
The firm issued recall letters to customers on 6/10/04. The recall was extended and URGENT EXTENSION OF PRODUCT RECALL notices were sent out on June 23, 2004.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Introducer tubing may contain a vein of unextruded material and carbon black or a strand of tubing material may be displaced from the introducer during use.
Acción
The firm issued recall letters to customers on 6/10/04. The recall was extended and URGENT EXTENSION OF PRODUCT RECALL notices were sent out on June 23, 2004.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Introducer tubing may contain a vein of unextruded material and carbon black or a strand of tubing material may be displaced from the introducer during use.
Acción
The firm issued recall letters to customers on 6/10/04. The recall was extended and URGENT EXTENSION OF PRODUCT RECALL notices were sent out on June 23, 2004.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Mask, Oxygen, Non-Rebreathing - Product Code KGB
Causa
The non-rebreathing masks and watertraps were manufactured with natural rubber or rubber by-products and were not labeled appropriately as containinig latex.
Acción
Medex telephoned the direct accounts on 7/12/04, and will fax and mail follow-up recall letters dated 7/2/04 on 7/13/04, informing them that the affected products were manufactured with natural rubber or rubber by-products and were not labeled appropriately as containing latex. The accounts were requested to cease distribution/use of the affected lots and return them to Medex for free replacement. The accounts were asked to contact Customer Service at 1-800-848-1757 to make arrangements for the return and replacement of their affected product. Distributors were requested to sub-recall the products from their customers. Any questions were directed to Terri Davis at 1-800-848-1757, ext. 5542.
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.
Introducer tubing may contain a vein of unextruded material and carbon black or a strand of tubing material may be displaced from the introducer during use.
Acción
The firm issued recall letters to customers on 6/10/04. The recall was extended and URGENT EXTENSION OF PRODUCT RECALL notices were sent out on June 23, 2004.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Introducer tubing may contain a vein of unextruded material and carbon black or a strand of tubing material may be displaced from the introducer during use.
Acción
The firm issued recall letters to customers on 6/10/04. The recall was extended and URGENT EXTENSION OF PRODUCT RECALL notices were sent out on June 23, 2004.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Introducer tubing may contain a vein of unextruded material and carbon black or a strand of tubing material may be displaced from the introducer during use.
Acción
The firm issued recall letters to customers on 6/10/04. The recall was extended and URGENT EXTENSION OF PRODUCT RECALL notices were sent out on June 23, 2004.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Mask, Oxygen, Non-Rebreathing - Product Code KGB
Causa
The non-rebreathing masks and watertraps were manufactured with natural rubber or rubber by-products and were not labeled appropriately as containinig latex.
Acción
Medex telephoned the direct accounts on 7/12/04, and will fax and mail follow-up recall letters dated 7/2/04 on 7/13/04, informing them that the affected products were manufactured with natural rubber or rubber by-products and were not labeled appropriately as containing latex. The accounts were requested to cease distribution/use of the affected lots and return them to Medex for free replacement. The accounts were asked to contact Customer Service at 1-800-848-1757 to make arrangements for the return and replacement of their affected product. Distributors were requested to sub-recall the products from their customers. Any questions were directed to Terri Davis at 1-800-848-1757, ext. 5542.
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.
Introducer tubing may contain a vein of unextruded material and carbon black or a strand of tubing material may be displaced from the introducer during use.
Acción
The firm issued recall letters to customers on 6/10/04. The recall was extended and URGENT EXTENSION OF PRODUCT RECALL notices were sent out on June 23, 2004.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Introducer tubing may contain a vein of unextruded material and carbon black or a strand of tubing material may be displaced from the introducer during use.
Acción
The firm issued recall letters to customers on 6/10/04. The recall was extended and URGENT EXTENSION OF PRODUCT RECALL notices were sent out on June 23, 2004.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Introducer tubing may contain a vein of unextruded material and carbon black or a strand of tubing material may be displaced from the introducer during use.
Acción
The firm issued recall letters to customers on 6/10/04. The recall was extended and URGENT EXTENSION OF PRODUCT RECALL notices were sent out on June 23, 2004.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Introducer tubing may contain a vein of unextruded material and carbon black or a strand of tubing material may be displaced from the introducer during use.
Acción
The firm issued recall letters to customers on 6/10/04. The recall was extended and URGENT EXTENSION OF PRODUCT RECALL notices were sent out on June 23, 2004.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Introducer tubing may contain a vein of unextruded material and carbon black or a strand of tubing material may be displaced from the introducer during use.
Acción
The firm issued recall letters to customers on 6/10/04. The recall was extended and URGENT EXTENSION OF PRODUCT RECALL notices were sent out on June 23, 2004.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Introducer tubing may contain a vein of unextruded material and carbon black or a strand of tubing material may be displaced from the introducer during use.
Acción
The firm issued recall letters to customers on 6/10/04. The recall was extended and URGENT EXTENSION OF PRODUCT RECALL notices were sent out on June 23, 2004.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Introducer tubing may contain a vein of unextruded material and carbon black or a strand of tubing material may be displaced from the introducer during use.
Acción
The firm issued recall letters to customers on 6/10/04. The recall was extended and URGENT EXTENSION OF PRODUCT RECALL notices were sent out on June 23, 2004.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Introducer tubing may contain a vein of unextruded material and carbon black or a strand of tubing material may be displaced from the introducer during use.
Acción
The firm issued recall letters to customers on 6/10/04. The recall was extended and URGENT EXTENSION OF PRODUCT RECALL notices were sent out on June 23, 2004.