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Recall Observatory FDA recall evidence

Device product

Injection Needle, curved 23 cm, REF: 8598A; Injection Needle, straight, 23 cm, REF: 8598B; Injection Needle, distal 45-degrees, 23 cm, REF: 8598D

Z-0575-2024

October 24, 2023

Class II

Product summary

Firm
Karl Storz Endoscopy
Event
Event 93328
Status
Ongoing
Classification
Class II
Quantity
4,878
Official record key
device-enforcement:Z-0575-2024

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: 8598A/04048551213278, 8598B/04048551001462, 8598D/04048551213285 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.