medical Class II Updated 2023-12-27

Karl Storz Endoscopy recalls Injection Needle, single cvd. 70 degrees, REF: 738750; Injec

Recalled Product

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, angular, 13 cm, REF: 738758; Needle, bayonet-shaped, REF: 810505; Needle, Septum, angular, REF: 810506


Hazard / Issue

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.

Issued by

FDA

Affected States: 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
Lot/Code Info: REF/UDI-DI: 738750/04048551195437, 738752/04048551195444, 738756/04048551195451, 738758/04048551195468, 810505/04048551203842, 810506/04048551001660 All lot numbers.
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