FDA-Device2022-03-23Class II
SAFE-T PLUS LUMBAR PUNCTURE TRAY ADULT
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
49,760 devices
Manufactured in
1625 W 3rd St Bldg 1, N/A, Tempe, AZ, United States
Products
SAFE-T PLUS LUMBAR PUNCTURE TRAY ADULT
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0794-2022Don't want to check this manually?
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