Medical Device Recall: LASER Application Instrument, 23 cm, REF: 8694; LEUNIG-GREVERS LASER Application, REF: 461000
Karl Storz Endoscopy · April 1, 2024
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.
States Affected
NATIONWIDE
Quantity Affected
85
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1809-2024
Status: ongoing
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