Sklar Instruments: ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE ROCH-PEAN FCP 8" CVD CS/25,Model Number 94-0286; 2) ECONO STERILE DRESSING FCP 5.5" CS/25LG,Model Number 94-0290; 3

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: 245015 units Lot/code info: 1) 94-0286, UDI/DI 50649111094406, Lot codes: FSF21; 2) 94-0290, UDI/DI 50649111095045, Lot codes: SK-115; 3) 94-0291, UDI/DI 50649111095144, Lot codes: 824940291, 924940291; 4) 941-0691, UDI/DI 50649111307902, Lot codes: MST8, MST9; 5) 941-1414, UDI/DI 50649111464872, Lot codes: SK-122; 6) 94-1924, UDI/DI 50649111345775, Lot codes: FSF16, FSF22; 7) 94-5034, UDI/DI 50649111040687, Lot codes: SK-112, SK-135; 8) 94-6146, UDI/DI 50649111215535, Lot codes: SK-135; 9) 94-6616, UDI/DI 50649111287457, Lot codes: SK-132; 10) 96-2215A, UDI/DI 50649111487567, Lot codes: HSI; 11) 96-2289, UDI/DI 50649111439986, Lot codes: SK-116; 12) 96-2293, UDI/DI 50649111440012, Lot codes: SK-115, SK-132; 13) 96-2293A, UDI/DI 50649111487598, Lot codes: HSI; 14) 96-2295A, UDI/DI 50649111493254, Lot codes: HST21; 15) 96-2351, UDI/DI 50649111440081, Lot codes: FST21; 16) 96-2386, UDI/DI 50649111440241, Lot codes: FSF18; 17) 96-2406, UDI/DI 50649111035195, Lot codes: FSF18, FSF24, FSF25; 18) 96-2408, UDI/DI 50649111035355, Lot codes: FSF5, FSF12, FSF18, FSF26; 19) 96-2410, UDI/DI 50649111035669, Lot codes: FST9; 20) 96-2412, UDI/DI 50649111035867, Lot codes: FST6, FST9, FST10, FST11, FST12, FST20; 21) 96-2412A, UDI/DI 50649111487550, Lot codes: SK-112; 22) 96-2412M, UDI/DI 50649111027015, Lot codes: 0724962412M; 23) 96-2450M, UDI/DI 50649111464483, Lot codes: 0624962450M; 24) 96-2461, UDI/DI 50649111440432, Lot codes: SK-132; 25) 96-2462, UDI/DI 50649111464490, Lot codes: SK-132; 26) 96-2470A, UDI/DI 506

UPC codes

50649111094406, 50649111095045, 50649111095144, 50649111307902, 50649111464872, 50649111345775, 50649111040687, 50649111215535, 50649111287457, 50649111487567, 50649111439986, 50649111440012, 50649111487598, 50649111493254, 50649111440081, 50649111440241, 50649111035195, 50649111035355, 50649111035669, 50649111035867, 50649111487550, 50649111027015, 50649111464483, 50649111440432, 50649111464490, 50649111487970, 50649111487987, 50649111050235, 50649111487857, 50649111053212, 50649111053397, 50649111487888, 50649111215313, 50649111478817, 50649111492653, 50649111488304, 50649111054172, 50649111220034, 50649111054424, 50649111219496

Source

Official record: FDA (Device enforcement) ↗

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