Z-2649-2023 Class II Ongoing
FDA device recall Z-2649-2023 was initiated by MEDLINE INDUSTRIES, LP - Northfield on May 23, 2023 and is designated Class II. Reason for recall: The kits incorrectly contain CirClamp subassembly 345CRSAK which results in the kits containing an incorrect bell and base size. The recall status is ongoing. Affected quantity: 106 units.
Recall Details
- Product Type
- Devices
- Report Date
- October 11, 2023
- Initiation Date
- May 23, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 106 units
Product Description
Centurion Sterile CirClamp with 1.45cm Bell Reprocessed, Reorder CR3145K, 1 per package, 12 per case.
Reason for Recall
The kits incorrectly contain CirClamp subassembly 345CRSAK which results in the kits containing an incorrect bell and base size.
Distribution Pattern
US Nationwide distribution.
Code Information
Lot #2022032501, exp. 2026-12-31, UDI-DI - (01)10653160312956