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FDA (Device enforcement)Recalled 2023-10-24class ii

Karl Storz Endoscopy: Injection Needle, single cvd. 70 degrees, REF: 738750; Injection Needle, single cvd. 80 degrees, REF: 738752; Injection Needle, bayonet, 13 cm, REF: 738756; Injection Needle, ang

Hazard

The efficacy of the manual cleaning process cannot be assured for the affected injection needles intended for general surgery and visceral surgery, which if used, may expose the patient to a higher risk of infection.

Details from the source

Reason for recall: The efficacy of the manual cleaning process cannot be assured for the affected injection needles intended for general surgery and visceral surgery, which if used, may expose the patient to a higher risk of infection. Distribution: US: MI, NH, SC, PA, FL, NY, NC, MS, MO, CA, NJ, IL, NV, OK, CO, OH, WA, WI, VA, IN, IA, AR, TX, WV, MD, MN, GA, MA, NM, VT, AK, OR, ID, LA, KS, DC, KY, HI OUS: Mexica, Canada, Germany Quantity: 4,470 Lot/code info: REF/UDI-DI: 738750/04048551195437, 738752/04048551195444, 738756/04048551195451, 738758/04048551195468, 810505/04048551203842, 810506/04048551001660 All lot numbers.

UPC codes

04048551195437, 04048551195444, 04048551195451, 04048551195468, 04048551203842, 04048551001660

Source

Official record: FDA (Device enforcement)

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

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