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U.S. Department of Health and Human Services

Class 1 Device Recall TriState Centurion Port Access Tray

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  Class 1 Device Recall TriState Centurion Port Access Tray see related information
Date Initiated by Firm January 14, 2009
Date Posted March 25, 2009
Recall Status1 Terminated 3 on December 31, 2009
Recall Number Z-1166-2009
Recall Event ID 50867
Product Classification Procedure Tray - Product Code LRS
Product Tri-State Centurion Port Access Tray, sterile, 20 per case, Tri-State Hospital Supply Corp., Howell, MI.; Reorder KNV75.
Code Information Lot 2008111450.
Recalling Firm/
Manufacturer		 Tri-State Hospital Supply Corporation
301 Catrell Drive
Howell MI 48843
For Additional Information Contact
517-546-5400 Ext. 1135
Manufacturer Reason
for Recall		 Lack of assurance of sterility, as the package seals may be inadequate.
FDA Determined
Cause 2		 Packaging process control
Action Tri-State Hospital Supply Corporation notified all consignees via Urgent Product Recall Notice letter dated January 14, 2009. Consignees were instructed to remove the product from inventory, to inform the firm of amount on hand, and to hold the product for retrieval.
Quantity in Commerce 340
Distribution Nationwide.
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.
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