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
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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/ Manufacturer |
Tri-State Hospital Supply Corporation 301 Catrell Drive Howell MI 48843
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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 |
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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.
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