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
Product summary
- 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
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.