Z-1407-2023 Class II Ongoing

Recalled by MEDLINE INDUSTRIES, LP - Northfield — Northfield, IL

FDA device recall Z-1407-2023 was initiated by MEDLINE INDUSTRIES, LP - Northfield on March 2, 2023 and is designated Class II. Reason for recall: The CirClamp subassembly found in the kit was the incorrect size. The recall status is ongoing. Affected quantity: 162 units.

Recall Details

Product Type
Devices
Report Date
April 26, 2023
Initiation Date
March 2, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
162 units

Product Description

Centurion CirClamp with 1.3cm Bell & Insert Reprocessed, Reorder #CR230K, Sterile.

Reason for Recall

The CirClamp subassembly found in the kit was the incorrect size.

Distribution Pattern

US Nationwide distribution in the states of CA and TX. There was no foreign/government/military distribution.

Code Information

Lot #2022070590, Exp. 2026-08-31, UDI (01)10653160312895(10)2022070590(17)260831.