Olympus Corporation of the Americas: ESG PK CUTTING FORCEPS, 5MM, 33CM

Hazard

The jaw may fracture prior to the procedure during the inspection instructed per the IFU, or during the procedure.

Details from the source

Reason for recall: The jaw may fracture prior to the procedure during the inspection instructed per the IFU, or during the procedure. Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Canada, Germany, Mexico, P.R. China, Singapore, South Korea. Quantity: 11,123 units Lot/code info: Model: PK-CF0533; UDI DI: 00821925035867; Lot Numbers: FR258486, FR261738, FR259544, FR263183, FR276278, FR279757, FR279625, FR279658, FR286369, FR287112, FR374622, FR207935, FR212413, FR212735, FR215061, FR216817, FR220525, FR222456, FR227254, FR227774, FR227781, FR232882, FR234845, FR247614, FR240430, FR246627, FR247039, FR248008, FR255679, FR248312, FR263636, FR263244, FR269280, FR269267, FR269269, FR287114, FR303799, FR297022, FR301062, PWO-308561, PWO-308562, PWO-308563, PWO-308560, PWO-308567, PWO-308566, PWO-308565, FR303864, FR313639, FR316869, FR319703, FR316872, FR327890, PWO-308972, FR335984, FR335990, FR337947, FR373912, FR401646, FR379790, FR347006;

UPC codes

00821925035867

Source

Official record: FDA (Device enforcement) ↗

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