Z-0796-2022 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
- 29,870 devices
Product Description
LUMBAR PUNCTURE TRAY ADULT 22G X3.5 STRL
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: 4306C Lot Numbers/UDI (GTIN, DI + PI): 0001410709 (01)10885403057069(17)220331(10)0001410709 0001411249 (01)10885403057069(17)220331(10)0001411249 0001412995 (01)10885403057069(17)220331(10)0001412995 0001414260 (01)10885403057069(17)220331(10)0001414260 0001414360 (01)10885403057069(17)220430(10)0001414360 0001415852 (01)10885403057069(17)220331(10)0001415852 0001417193 (01)10885403057069(17)220430(10)0001417193 0001415027 (01)10885403057069(17)220430(10)0001415027 0001419336 (01)10885403057069(17)220430(10)0001419336 0001422223 (01)10885403057069(17)220630(10)0001422223 0001425520 (01)10885403057069(17)220630(10)0001425520 0001426674 (01)10885403057069(17)220630(10)0001426674 0001428621 (01)10885403057069(17)220630(10)0001428621 0001429518 (01)10885403057069(17)220630(10)0001429518 0001430118 (01)10885403057069(17)220630(10)0001430118 0001433265 (01)10885403057069(17)220831(10)0001433265 0001433844 (01)10885403057069(17)220930(10)0001433844 0001434817 (01)10885403057069(17)220930(10)0001434817 0001438147 (01)10885403057069(17)221031(10)0001438147