Sklar Instruments: ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE HEGAR DILATOR 11&12MM STRLCS25Model Number 96-0960; 2) ECONO STERILE HEGAR DILATOR 9&10MM STRL CS25Model Number 96-

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: 75 units Lot/code info: 1) 96-0960, UDI/DI 50649111474796, Lot codes: FSS5; 2) 96-0961, UDI/DI 50649111474802, Lot codes: FSS5; 3) 96-0962, UDI/DI 50649111474819, Lot codes: FSS5; 4) 96-0963, UDI/DI 50649111474826, Lot codes: FSS5; 5) 96-0964, UDI/DI 50649111474833, Lot codes: FSS5; 6) 96-0965, UDI/DI 50649111474840, Lot codes: FSS5; 7) 96-0966, UDI/DI 50649111474857, Lot codes: SK-119.

UPC codes

50649111474796, 50649111474802, 50649111474819, 50649111474826, 50649111474833, 50649111474840, 50649111474857

Source

Official record: FDA (Device enforcement) ↗

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