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Recall Observatory FDA recall evidence

Device product

ADULT LUMBAR PUNCTURE DRUG FREE TRAY 20G

Z-0793-2022

January 20, 2022

Class II

Product summary

Firm
Bard Peripheral Vascular Inc
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

    reason.no_named_rule · v1.0.0

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