Sklar Instruments: Medical procedure kits labeled as: 1) ECONO STERILE STRABIS SCISS STR 4.5"STER 50, Model Number 96-2540; 2) ECONO STERILE STRABIS SCISS CVD 4.5"STER 50, Model Number 96-2541; 3) ECO

Hazard

Reports of various packaging issues that may result in a breach of the sterile barrier.

Details from the source

Reason for recall: Reports of various packaging issues that may result in a breach of the sterile barrier. Distribution: Domestic: Nationwide Distribution Quantity: 350 units Lot/code info: 1) 96-2540, UDI/DI 50649111054967, Lot codes: FSS8, FSS10; 2) 96-2541, UDI/DI 50649111055087, Lot codes: FSS10; 3) 96-2542, UDI/DI 50649111055391, Lot codes: FSS10; 4) 96-2542M, UDI/DI 50649111440685, Lot codes: MSS10.

UPC codes

50649111054967, 50649111055087, 50649111055391, 50649111440685

Source

Official record: FDA (Device enforcement) ↗

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