FDA-Device2022-03-23Class II

LUMBAR PUNCTURE DRUG FREE TRAY 22G

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
2,880 devices
Manufactured in
1625 W 3rd St Bldg 1, N/A, Tempe, AZ, United States
Products
LUMBAR PUNCTURE DRUG FREE TRAY 22G

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0799-2022

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