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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 Traysee related information
Date Initiated by FirmApril 08, 2008
Date PostedJuly 07, 2009
Recall Status1 Terminated 3 on November 19, 2009
Recall NumberZ-1573-2009
Recall Event ID 52130
Product Classification Port Access Tray - Product Code OKE
ProductTri-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
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
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.
Quantity in Commerce100 trays
DistributionIndiana, Mississippi, Ohio and Tennessee.
Total Product Life CycleTPLC 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.
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