Class 2 Device Recall SKU: CR3145K CIRCLAMP W/1.45CM BELL STREPROCESSED

• Date Initiated by Firm: May 23, 2023
• Date Posted: September 29, 2023
• Recall Status: Open, Classified
• Recall Number: Z-2649-2023
• Recall Event ID: 92883
• 510(K)Number: K890897
• Product Classification: Clamp, circumcision - Product Code HFX
• Product: Centurion Sterile CirClamp with 1.45cm Bell Reprocessed, Reorder CR3145K, 1 per package, 12 per case.
• Code Information: Lot #2022032501, exp. 2026-12-31, UDI-DI - (01)10653160312956
• 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 kits incorrectly contain CirClamp subassembly 345CRSAK which results in the kits containing an incorrect bell and base size.
• FDA Determined Cause: Process control
• Action: The recalling firm issued letters dated 5/23/2023 via email and first class mail on 5/23/2023 to its consignees, which identified incorrect information regarding the affected product. It had stated the label indicates the kit contains a 1.3 cm bell and insert; however the kit actually contains a 1.45 cm bell and insert. The affected kits were to be destroyed for credit and none were to be returned to the recalling firm. The consignee was to check their stock for the affected item number and lot numbers listed on the recalling firm's recall portal and destroy the affected product. A link was provided to complete the response form. If the consignee is a distributor or has resold or transferred the product to another company or individual, they are to notify them of this recall communication. The recalling firm issued a letter flagged as an Amended Letter dated 9/1/2023 via email and first class mail that alerted the consignee to the incorrect product information contained in the initial 5/23/2023 letter and the Amended Letter provided the correct product information, that being the product is supposed to include a 1.45 cm base and 1.45cm bell, however, the kit incorrectly contains CirClamp subassembly 345CRSAK which includes a 1.6cm base and 1.6cm bell. The letter instructs that affected kits can be destroyed for credit and no kits are to be returned to Medline. The consignee is instructed to immediately check their stock for the item number and lot number listed in the letter and on the destruction form, quarantine the affected product, and destroy it. The enclosed destruction form listing the quantity of affected product destroyed is to be returned. If the product has been transferred to another individual, department or location , the consignee is to notify them of this recall communication.
• Quantity in Commerce: 106 units
• Distribution: US Nationwide 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 and Original Applicant = TRI-STATE HOSPITAL SUPPLY CORP.