Class 2 Device Recall Centurion CirClamp

• Date Initiated by Firm: March 02, 2023
• Date Posted: April 19, 2023
• Recall Status: Open, Classified
• Recall Number: Z-1407-2023
• Recall Event ID: 91894
• 510(K)Number: K890897
• Product Classification: Clamp, circumcision - Product Code HFX
• Product: Centurion CirClamp with 1.3cm Bell & Insert Reprocessed, Reorder #CR230K, Sterile.
• Code Information: Lot #2022070590, Exp. 2026-08-31, UDI (01)10653160312895(10)2022070590(17)260831.
• FEI Number: 1417592
• Recalling Firm/ Manufacturer: MEDLINE INDUSTRIES, LP - Northfield ; 3 Lakes Dr; Northfield IL 60093-2753
• For Additional Information Contact: Karin Johnson; 886-359-1704
• Manufacturer Reason for Recall: The CirClamp subassembly found in the kit was the incorrect size.
• FDA Determined Cause: Under Investigation by firm
• Action: The recalling firm issued letters dated 3/2/2023 via first class mail informing the consignee of the issue and to remove it from stock and dispose of it. The letter provided required actions which again included destroying the affected product and to return the completed enclosed destruction form listing the quantity of affected product destroyed. Once the destruction form is received, the account will be issued a credit. If the device has been transferred to another individual, department or location, the consignee is to notify them of this recall communication.
• Quantity in Commerce: 162 units
• Distribution: US Nationwide distribution in the states of CA and TX. There was no foreign/government/military distribution.
• 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

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