Reports of various packaging issues that may result in a breach of the sterile barrier.
Reason for recall: Reports of various packaging issues that may result in a breach of the sterile barrier. Distribution: Domestic: Nationwide Distribution Quantity: 7730 units Lot/code info: 1) 96-2424A, UDI/DI 50649111484504, Lot codes: SK-112; 2) 96-2427, UDI/DI 50649111449008, Lot codes: SK-131; 3) 96-2666, UDI/DI 50649111078918, Lot codes: SK-118; 4) 96-2666A, UDI/DI 50649111488120, Lot codes: SK-112, SK-118; 5) 96-2667, UDI/DI 50649111079090, Lot codes: SK-118; 6) 96-2671A, UDI/DI 50649111488113, Lot codes: SK-112.
50649111484504, 50649111449008, 50649111078918, 50649111488120, 50649111079090, 50649111488113
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.