Centurion CirClamp with 1.3cm Bell & Insert Reprocessed, Reorder #CR230K, Sterile.
- Recall Initiated
- March 2, 2023
- Posted
- April 19, 2023
- Recall Number
- Z-1407-2023
- Quantity
- 162 units
- Firm Location
- Northfield, IL
Reason for Recall
The CirClamp subassembly found in the kit was the incorrect size.
Distribution
US Nationwide distribution in the states of CA and TX. There was no foreign/government/military distribution.
Lot / Code Info
Lot #2022070590, Exp. 2026-08-31, UDI (01)10653160312895(10)2022070590(17)260831.
Root Cause
Under Investigation by firm
Action Taken
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.