Device product
ADULT LUMBAR PUNCTURE DRUG FREE TRAY 20G
Z-0793-2022
Product summary
- Event
- Event 89553
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1260 devices
- Official record key
device-enforcement:Z-0793-2022
Official wording
Reason: Due to lumbar puncture tray manometer failure mode of leaking and mating issues.
Code information: Catalog Number: 4301CDF Lot Numbers/UDI (GTIN, DI + PI): 0001433537 (01)10885403231810(17)260831(10)0001433537 0001437269 (01)10885403231810(17)260930(10)0001437269
Distribution pattern: U.S. Nationwide Distribution: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. O.U.S. (foreign) including states: Costa Rica and Hong Kong.
Derived failure modes
-
Unknown
Due to lumbar puncture tray manometer failure mode of leaking and mating issues.