Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1572-2009

Tri-State Hospital Supply Corporation, Tri-State Centurion CVC (Central Venous Catheter) Bundles, Qty/case...

Centurion Medical Products, LP / initiated 2008-04-08 / Terminated / root cause: manufacturing process

Tri-State Hospital Supply Corporation began a recall of Tri-State Hospital Supply Corporation, Tri-State Centurion CVC (Central Venous Catheter) Bundles, Qty/case 10, sterile, Code no./Reorder DT10710. Each bundle... on . The reason FDA records is "The kits contain Monoject prefill heparin lock flush syringes, which were recalled by the manufacturer due to contamination". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-1572-2009
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Centurion Medical Products, LP
Product
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.
Product code
OFF Central Venous Catheter Tray
Reason for recall
The kits contain Monoject prefill heparin lock flush syringes, which were recalled by the manufacturer due to contamination.
Root cause tag
manufacturing process
FDA 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 in commerce
110 bundles
Distribution
Indiana, Mississippi, Ohio and Tennessee.
Product codes and lots
Bundles lots 801288 and 811127. Heparin flush lots 7041194 and 7113154.