MEDLINE INDUSTRIES, LP - Northfield: Centurion scalpel handle kits labeled as: a) STERILE # 3 SCALPEL HANDLE, Product Code 66825; b) STERILE PAS #3 BLADE HANDLE (BH3PAS), Product Code I68290

Hazard

Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.

Details from the source

Reason for recall: Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users. Distribution: Worldwide distribution - US Nationwide and the countries of Panama, Canada. Quantity: 3860 units Lot/code info: a) 66825, UDI/DI 60653160053588 (case) 00653160053586 (each), Lot Numbers: 2023091990, 2023111590; b) I68290 UDI/DI 00653160275056 (case) 10653160275053 (each), Lot Numbers: 2023100690

UPC codes

60653160053588, 00653160053586, 00653160275056, 10653160275053

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.