Recall Z-1571-2009 ยท OKE Port Introducer Kit
Tri-State Hospital Supply Corporation
Tri-State Hospital Supply Corp., Tri-State Centurion Venous Access Port Kits, Qty/case 20, sterile, Code No./Reorder KNV80. Each kit contains 1 sterile heparin flush injection solution as follows: Tyco Healthcare Monoject Prefill 100U/mL Heparin Lock Flush Syringe, 10mL, REF # 8881590121.
| Date | Jul 7, 2009 (initiated Apr 8, 2008) |
| Status | Terminated |
| Reason | The kits contain Monoject prefill heparin lock flush syringes, which were recalled by the manufacturer due to contamination. |
| Root cause | Material/Component Contamination |
| Action | 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. |
| Quantity | 100 kits |
| Distribution | Indiana, Mississippi, Ohio and Tennessee. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.