Olympus Corporation of the Americas: TRACHEAL INTUBATION FIBERSCOPE OLYMPUS LF-GP, Model Number: LF-GP

Hazard

Fiberscopes do not have adequate data to support that the suction flow rate meets the device specification.

Details from the source

Reason for recall: Fiberscopes do not have adequate data to support that the suction flow rate meets the device specification. Distribution: Worldwide - US Nationwide distribution in the states of AK, AL, AZ, CA, GA, IL, IN, MA, MD, MI, NC, NJ, OH, TX, UT, VA, WA, WV & AP (Armed Forces Pacific) and the countries of OUS: EMEA, Japan and Australia. Quantity: 75 Lot/code info: UDI-DI: 04953170340215 & UDI-DI: 04953170061998. Serial numbers: 2515143, 2515181, 2515449, 2515549, 2615760, 2615761, 2615763, 2615825, 2615830, 2615831, 2616057, 2616130, 2616199, 2716417, 2817430, 2917855, 2917867, 2917997, 2918003, 2918010, 2918012, 2918030, 2018337, 2018435, 2018486, 2018543, 2018571, 2018675, 2319768, 2319820, 2510582, 2621001.

UPC codes

04953170340215, 04953170061998

Source

Official record: FDA (Device enforcement) ↗

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