Z-0573-2024 Class II Ongoing
FDA device recall Z-0573-2024 was initiated by Karl Storz Endoscopy on October 24, 2023 and is designated Class II. 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 ri… The recall status is ongoing. Affected quantity: 1,127.
Recall Details
- Product Type
- Devices
- Report Date
- December 27, 2023
- Initiation Date
- October 24, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,127
Product Description
Injection Needle, LUER-lock,0.8mm, REF: 26175PD
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 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
Code Information
UDI-DI: 04048551099391. All lot numbers.