Class 3 Device Recall Centurion

• Date Initiated by Firm: April 12, 2005
• Date Posted: May 12, 2005
• Recall Status: Terminated on September 08, 2005
• Recall Number: Z-0836-05
• Recall Event ID: 31645
• 510(K)Number: K890897
• Product Classification: Clamp, Circumcision - Product Code HFX
• Product: Centurion brand CirClamp with 1.3 cm bell, sterile, single use; product 330.
• Code Information: Lots 11224 and 06284.
• Recalling Firm/ Manufacturer: Tri-State Hospital Supply Corp; 301 Catrell Dr; Howell MI 48843-1703
• For Additional Information Contact: Karen Kowalczyk; 517-546-5400 Ext. 1122
• Manufacturer Reason for Recall: Lot 11224 may contain a 1.1 cm clamp and bell and neither lot is labeled as reprocessed, when they have been reprocessed.
• FDA Determined Cause: Other
• Action: Consignees were notified to return the product via letter dated 4/12/05.
• Quantity in Commerce: 4078
• 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.

• 510(K) Database: 510(K)s with Product Code = HFX