FDA Recall
Terminated
Tri-State Centurion PICC Line Tray, sterile, 10 per case, Tri-State Hospital Supply Corp., Howell, MI.; Reorder CVI2370.
Recall: Z-1159-2009
·
Initiated January 14, 2009
Recall
- Recall Number
- Z-1159-2009
- Event Number
- 50867
- Firm
- Tri-State Hospital Supply Corporation
- FEI Number
- 1824619
- Product Code
- LRS
- Status
- Terminated
- Root Cause
- Packaging process control
- Initiated
- January 14, 2009
- Posted
- March 25, 2009
- Terminated
- December 31, 2009
- Address
- 301 Catrell Drive, Howell, MI, 48843
Description
Tri-State Centurion PICC Line Tray, sterile, 10 per case, Tri-State Hospital Supply Corp., Howell, MI.; Reorder CVI2370.
Reason
Lack of assurance of sterility, as the package seals may be inadequate.
Action
Tri-State Hospital Supply Corporation notified all consignees via Urgent Product Recall Notice letter dated January 14, 2009. Consignees were instructed to remove the product from inventory, to inform the firm of amount on hand, and to hold the product for retrieval.
Distribution
Nationwide.
Quantity
90