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FDA (Device enforcement)Recalled 2023-07-07class ii

Karl Storz Endoscopy: Five S 5 3x65, REF: 0915612-06, sterile for single use, Sterile EO, Rx Only

Hazard

Flexible intubation endoscopes sterility assurance can not be confirmed.

Details from the source

Reason for recall: Flexible intubation endoscopes sterility assurance can not be confirmed. Distribution: 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. Quantity: 218 units Lot/code info: UDI: 04048551446690/ All lots with remaining shelf life (Globally) Lots imported into the U.S.: 500472 & 500461

UPC codes

04048551446690

Source

Official record: FDA (Device enforcement)

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

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