Recall Z-1168-2009
Tri-State Hospital Supply Corporation · initiated January 14, 2009
Product
Tri-State Centurion Sutureless Multi-Lumen CVC Insertion Kit, sterile, 5 per case, Tri-State Hospital Supply Corp., Howell, MI.; Reorder ECVC175.
Codes / lots: Lot 2008111250.
Reason for recall
Lack of assurance of sterility, as the package seals may be inadequate.
FDA-determined cause: Packaging process control
Action taken
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.
Details
- Recall number
- Z-1168-2009
- Initiated
- January 14, 2009
- Posted by FDA
- March 25, 2009
- Terminated
- December 31, 2009
- Product code
- LRS – I.V. Start Kit
- Quantity
- 10
- Distribution
- Nationwide.
- Recalling firm
- Tri-State Hospital Supply Corporation, Howell, MI
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1157-2009 | Tri-State Centurion Chest Tube Insertion Tray, sterile, 6 per case, Tri-State Hospital…Lack of assurance of sterility, as the package seals may be inadequate. | 01/14/2009Terminated |
| Z-1158-2009 | Tri-State Centurion Chest Tube Insertion Tray (Dentry/Bardmoor), sterile, 6 per case…Lack of assurance of sterility, as the package seals may be inadequate. | 01/14/2009Terminated |
| Z-1159-2009 | Tri-State Centurion PICC Line Tray, sterile, 10 per case, Tri-State Hospital Supply…Lack of assurance of sterility, as the package seals may be inadequate. | 01/14/2009Terminated |
| Z-1160-2009 | Tri-State Centurion PICC Insertion Tray, sterile, 15 per case, Tri-State Hospital Supply…Lack of assurance of sterility, as the package seals may be inadequate. | 01/14/2009Terminated |
| Z-1161-2009 | Tri-State Centurion PICC/CVC Insertion Tray, sterile, 15 per case, Tri-State Hospital…Lack of assurance of sterility, as the package seals may be inadequate. | 01/14/2009Terminated |
| Z-1162-2009 | Lee Medical Neonatal/Ped PICC Insertion Tray, sterile, 15 per case, Lee Medical, Inc.…Lack of assurance of sterility, as the package seals may be inadequate. | 01/14/2009Terminated |
| Z-1163-2009 | Tri-State Centurion Port Access Kit, sterile, 20 per case, Tri-State Hospital Supply…Lack of assurance of sterility, as the package seals may be inadequate. | 01/14/2009Terminated |
| Z-1164-2009 | Tri-State Centurion Port Access Tray, sterile, 20 per case, Tri-State Hospital Supply…Lack of assurance of sterility, as the package seals may be inadequate. | 01/14/2009Terminated |
| Z-1165-2009 | Tri-State Centurion Port Access Tray, sterile, 20 per case, Tri-State Hospital Supply…Lack of assurance of sterility, as the package seals may be inadequate. | 01/14/2009Terminated |
| Z-1166-2009 | Tri-State Centurion Port Access Tray, sterile, 20 per case, Tri-State Hospital Supply…Lack of assurance of sterility, as the package seals may be inadequate. | 01/14/2009Terminated |
| Z-1167-2009 | Tri-State Centurion Implanted Access Port Tray, sterile, 16 per case, Tri-State Hospital…Lack of assurance of sterility, as the package seals may be inadequate. | 01/14/2009Terminated |
| Z-1169-2009 | Tri-State Centurion Umbilical Vessel Tray without catheter, sterile, 5 per tray…Lack of assurance of sterility, as the package seals may be inadequate. | 01/14/2009Terminated |