Class 1 Device Recall TriState Centurion Implanted Access Port Tray

• Date Initiated by Firm: January 14, 2009
• Date Posted: March 25, 2009
• Recall Status: Terminated on December 31, 2009
• Recall Number: Z-1167-2009
• Recall Event ID: 50867
• Product Classification: Procedure Tray - Product Code MCY
• Product: Tri-State Centurion Implanted Access Port Tray, sterile, 16 per case, Tri-State Hospital Supply Corp., Howell, MI.; Reorder DT7105.
• Code Information: Lot 2008110650.
• 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: 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: 288
• 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.