FDA-Device2023-09-27Class II
Five S 5 3x65, REF: 0915612-06, sterile for single use, Sterile EO, Rx Only
Karl Storz Endoscopy
Hazard
Flexible intubation endoscopes sterility assurance can not be confirmed.
Sold states
Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MEX, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, WY and the country of Canada.
Affected count
218 units
Manufactured in
2151 E Grand Ave, El Segundo, CA, United States
Products
Five S 5 3x65, REF: 0915612-06, sterile for single use, Sterile EO, Rx Only
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2589-2023Don't want to check this manually?
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