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Recall Observatory FDA recall evidence

Device 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

Z-0574-2024

October 24, 2023

Class II

Product summary

Firm
Karl Storz Endoscopy
Event
Event 93328
Status
Ongoing
Classification
Class II
Quantity
4,470
Official record key
device-enforcement:Z-0574-2024

Official wording

Reason: 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.

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

Distribution pattern: 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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.