Recall Z-1157-2009 ยท FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Tri-State Hospital Supply Corporation
Tri-State Centurion Chest Tube Insertion Tray, sterile, 6 per case, Tri-State Hospital Supply Corp., Howell, MI.; Reorder CHT620.
| Date | Mar 25, 2009 (initiated Jan 14, 2009) |
| Status | Terminated |
| Reason | Lack of assurance of sterility, as the package seals may be inadequate. |
| Root cause | Packaging process control |
| 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. |
| Quantity | 12 |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.