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U.S. Department of Health and Human Services

Class 2 Device Recall TriState Centurion Incision & Drainage Tray

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  Class 2 Device Recall TriState Centurion Incision & Drainage Tray see related information
Date Initiated by Firm January 14, 2009
Date Posted April 30, 2009
Recall Status1 Terminated 3 on December 24, 2009
Recall Number Z-1321-2009
Recall Event ID 51439
Product Classification Kit, surgical instrument, disposable - Product Code KDD
Product Tri-State Centurion Incision and Drainage Tray, sterile, 20 per case, Tri-State Hospital Supply Corp., Howell, MI; Reorder ID615.
Code Information Lot Number: 2008111450.
Recalling Firm/
Tri-State Hospital Supply Corporation
301 Catrell Drive
Howell MI 48843
For Additional Information Contact
Manufacturer Reason
for Recall
Compromised sterility, as the package seals may be inadequate.
FDA Determined
Cause 2
Packaging process control
Action A letter titled "Urgent Product Recall Notice" was sent by Tri-State Hospital Supply Corporation to all consignees via certified mail titled dated January 14, 2009. Consignees were instructed to remove the product from inventory, to inform the firm of amount on hand by sending the Accountability Information Form to the firm via fax (1-517-546-3356) or email and to hold the product for retrieval. Further questions should be addressed to Tri-State Hospital Supply Corp. at 1-517-546-5400 extension 1135.
Quantity in Commerce 140
Distribution Nationwide including states of NC, FL, TX, NJ, IL, MA, GA and IA.
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.