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U.S. Department of Health and Human Services

Class 2 Device Recall TriState Centurion Port Access Tray

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  Class 2 Device Recall TriState Centurion Port Access Tray see related information
Date Initiated by Firm April 08, 2008
Date Posted July 07, 2009
Recall Status1 Terminated 3 on November 19, 2009
Recall Number Z-1573-2009
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 DT9405B. 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 801218 and 803178. Heparin flush lots 7082284 and 7113154.
Recalling Firm/
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 2
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 100 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.