ClearanceBrief
Recall Z-1572-2009 ยท OFF Central Venous Catheter Tray

Tri-State Hospital Supply Corporation

Tri-State Hospital Supply Corporation, Tri-State Centurion CVC (Central Venous Catheter) Bundles, Qty/case 10, sterile, Code no./Reorder DT10710. Each bundle contains 3 sterile heparin flush injection solutions as follows: Tyco Healthcare Monoject Prefill100U/mL Heparin Lock Flush Syringe, 5mL, REF # 8881590125.

DateJul 7, 2009 (initiated Apr 8, 2008)
StatusTerminated
ReasonThe kits contain Monoject prefill heparin lock flush syringes, which were recalled by the manufacturer due to contamination.
Root causeMaterial/Component Contamination
ActionTri 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.
Quantity110 bundles
DistributionIndiana, Mississippi, Ohio and Tennessee.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.