Device product

LUMBAR PUNCTURE DRUG FREE TRAY 22G

Z-0799-2022

January 20, 2022

Class II

Product summary

Firm: Bard Peripheral Vascular Inc
Event: Event 89553
Status: Ongoing
Classification: Class II
Quantity: 2,880 devices
Official record key: device-enforcement:Z-0799-2022

Official wording

Reason: Due to lumbar puncture tray manometer failure mode of leaking and mating issues.

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

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
reason.no_named_rule · v1.0.0

Due to lumbar puncture tray manometer failure mode of leaking and mating issues.