Recall Z-1573-2009
Tri-State Hospital Supply Corporation · initiated April 8, 2008
Product
Tri-State Hospital Supply Corp., Tri-State Centurion Port Access Trays, Qty/case 20, sterile, Code no./reorder DT9405B. Each tray contains 1 sterile heparin flush injection solution as follows: Tyco Healthcare Monoject Prefill100U/mL Heparin Lock Flush Syringe, 5mL, REF # 8881590125.
Codes / lots: Tray lots 801218 and 803178. Heparin flush lots 7082284 and 7113154.
Reason for recall
The kits contain Monoject prefill heparin lock flush syringes, which were recalled by the manufacturer due to contamination.
FDA-determined cause: Material/Component Contamination
Action taken
Tri State Hospital notified their consignees by letter dated 4/8/08 and instructed to discontinue use of the product and to either discard or return it.
Details
- Recall number
- Z-1573-2009
- Initiated
- April 8, 2008
- Posted by FDA
- July 7, 2009
- Terminated
- November 19, 2009
- Product code
- OKE – Port Introducer Kit
- Quantity
- 100 trays
- Distribution
- Indiana, Mississippi, Ohio and Tennessee.
- Recalling firm
- Tri-State Hospital Supply Corporation, Howell, MI
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1571-2009 | Tri-State Hospital Supply Corp., Tri-State Centurion Venous Access Port Kits, Qty/case…The kits contain Monoject prefill heparin lock flush syringes, which were recalled by the manufacturer due… | 04/08/2008Terminated |
| Z-1572-2009 | Tri-State Hospital Supply Corporation, Tri-State Centurion CVC (Central Venous Catheter)…The kits contain Monoject prefill heparin lock flush syringes, which were recalled by the manufacturer due… | 04/08/2008Terminated |
| Z-1574-2009 | Tri-State Hospital Supply Corp., Tri-State Centurion Port Blood Draw Trays, Qty/case 20…The kits contain Monoject prefill heparin lock flush syringes, which were recalled by the manufacturer due… | 04/08/2008Terminated |
| Z-1575-2009 | Tri-State Hospital Supply Corp., Tri-State Centurion Port Access Trays, Qty/case 20…The kits contain Monoject prefill heparin lock flush syringes, which were recalled by the manufacturer due… | 04/08/2008Terminated |