Device product

SAFE-T PLUS ATRAUMATIC ADULT LP TRAY

Z-0800-2022

January 20, 2022

Class II

Product summary

Firm: Bard Peripheral Vascular Inc
Event: Event 89553
Status: Ongoing
Classification: Class II
Quantity: 3,240 devices
Official record key: device-enforcement:Z-0800-2022

Official wording

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

Code information: Catalog Number: 4306CWSP Lot Numbers/UDI (GTIN, DI + PI): 0001416832 (01)10885403229008(17)220430(10)0001416832 0001417843 (01)10885403229008(17)220430(10)0001417843 0001421009 (01)10885403229008(17)220531(10)0001421009 0001424764 (01)10885403229008(17)220630(10)0001424764 0001428872 (01)10885403229008(17)220630(10)0001428872 0001436145 (01)10885403229008(17)220930(10)0001436145

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.