Class 2 Device Recall TriState Centurion Port Access Tray

• Date Initiated by Firm: April 08, 2008
• Date Posted: July 07, 2009
• Recall Status: Terminated on November 19, 2009
• Recall Number: Z-1575-2009
• Recall Event ID: 52130
• Product Classification: Port Access Tray - Product Code OKE
• Product: Tri-State Hospital Supply Corp., Tri-State Centurion Port Access Trays, Qty/case 20, sterile, Code no./reorder KNV50. Each tray contains 1 sterile heparin flush injection solution as follows: Tyco Healthcare Monoject Prefill100U/mL Heparin Lock Flush Syringe, 5mL, REF # 8881590125.
• Code Information: Tray lots 801148, 801158 and 811127. Heparin flush lots 7072064 and 7082284.
• Recalling Firm/ Manufacturer: Tri-State Hospital Supply Corporation; 301 Catrell Drive; Howell MI 48843
• For Additional Information Contact: 517-546-5400 Ext. 1156
• Manufacturer 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: 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: 460 trays
• Distribution: Indiana, Mississippi, Ohio and Tennessee.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.