FDA-Device2022-03-23Class II

LUMBAR PUNCTURE TRAY PEDIATRIC 21G 2.5

Bard Peripheral Vascular Inc
Hazard

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

Sold states
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.
Affected count
11,970 devices
Manufactured in
1625 W 3rd St Bldg 1, N/A, Tempe, AZ, United States
Products
LUMBAR PUNCTURE TRAY PEDIATRIC 21G 2.5

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0791-2022

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