Device product
Centurion CirClamp with 1.3cm Bell & Insert Reprocessed, Reorder #CR230K, Sterile.
Z-1407-2023
Product summary
- Event
- Event 91894
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 162 units
- Official record key
device-enforcement:Z-1407-2023
Official wording
Reason: The CirClamp subassembly found in the kit was the incorrect size.
Code information: Lot #2022070590, Exp. 2026-08-31, UDI (01)10653160312895(10)2022070590(17)260831.
Distribution pattern: US Nationwide distribution in the states of CA and TX. There was no foreign/government/military distribution.
Derived failure modes
-
Unknown
The CirClamp subassembly found in the kit was the incorrect size.