Class 2 Device Recall TriState Centurion Plastic Laceration Set

• Date Initiated by Firm: January 14, 2009
• Date Posted: April 30, 2009
• Recall Status: Terminated on December 24, 2009
• Recall Number: Z-1322-2009
• Recall Event ID: 51439
• Product Classification: Kit, suture removal - Product Code MCZ
• Product: Tri-State Centurion Plastic Laceration Set, sterile, 16 per case, Tri-State Hospital Supply Corp., Howell, MI; Reorder SUT3390.
• Code Information: Lot Number: 2008111750.
• Recalling Firm/ Manufacturer: Tri-State Hospital Supply Corporation; 301 Catrell Drive; Howell MI 48843
• For Additional Information Contact: 517-546-5400
• Manufacturer Reason for Recall: Compromised sterility, as the package seals may be inadequate.
• FDA Determined Cause: 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: 112
• 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.