FDA recall Z-0797-2022

Bard Peripheral Vascular Inc · Class II · device

Product

SAFE-T PLUS LUMBARPUNCTURE TRAY ADULT

Reason for recall

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

Distribution

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.

Key facts

Status: Ongoing
Initiation date: 2022-01-20
Report date: 2022-03-23
Voluntary/Mandated: Voluntary: Firm initiated
Location: Tempe, AZ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0797-2022