Z-0799-2022 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- March 23, 2022
- Initiation Date
- January 20, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,880 devices
Product Description
LUMBAR PUNCTURE DRUG FREE TRAY 22G
Reason for Recall
Due to lumbar puncture tray manometer failure mode of leaking and mating issues.
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.
Code Information
Catalog Number: 4306CWDF Lot Numbers/UDI (GTIN, DI + PI): 0001415023 (01)10885403231827(17)250731(10)0001415023 0001416353 (01)10885403231827(17)250731(10)0001416353 0001420159 (01)10885403231827(17)250731(10)0001420159 0001424771 (01)10885403231827(17)250731(10)0001424771 0001437270 (01)10885403231827(17)250731(10)0001437270