Karl Storz Endoscopy: LASER Application Instrument, 23 cm, REF: 8694; LEUNIG-GREVERS LASER Application, REF: 461000

Hazard

Laser surgical instruments have no specific evidence of a validated reprocessing method, therefore these instruments lack sterility assurance, so once the instruments have gone through reprocessing after use and then are used again, there is an increased risk of the patient being exposed to infection.

Details from the source

Reason for recall: Laser surgical instruments have no specific evidence of a validated reprocessing method, therefore these instruments lack sterility assurance, so once the instruments have gone through reprocessing after use and then are used again, there is an increased risk of the patient being exposed to infection. Distribution: Worldwide distribution - US Nationwide in the states of OH, CA, FL, MA, TX, KY, WI, MI, MN, AR, NE, IL, NY, HI and the country of Argentina. Quantity: 85 Lot/code info: All lots. REF/UDI-DI: 8694/04048551216392, 461000/04048551164860

UPC codes

04048551216392, 04048551164860

Source

Official record: FDA (Device enforcement) ↗

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