Product Safety Recalls

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Bard Peripheral Vascular Inc Recall 89553

Description: SAFE-T PLUS LUMBAR PUNCTURE TRAY ADULT

Bard Peripheral Vascular Inc Recall 89553 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0794-2022
Event ID89553
Event DescriptionSAFE-T PLUS LUMBAR PUNCTURE TRAY ADULT
Product TypeDevices
DistributionU.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.
Quantity49,760 devices
Recall ReasonDue to lumbar puncture tray manometer failure mode of leaking and mating issues.
Device Classification20220323
Device Code InfoCatalog Number: 4301CSP Lot Numbers/UDI (GTIN, DI + PI): 0001411297 (01)10885403107771(17)220331(10)0001411297 0001412994 (01)10885403107771(17)220331(10)0001412994 0001412993 (01)10885403107771(17)220331(10)0001412993 0001413312 (01)10885403107771(17)220331(10)0001413312 0001413224 (01)10885403107771(17)220331(10)0001413224 0001415321 (01)10885403107771(17)220430(10)0001415321 0001416350 (01)10885403107771(17)220331(10)0001416350 0001416833 (01)10885403107771(17)220430(10)0001416833 0001417546 (01)10885403107771(17)220430(10)0001417546 0001418031 (01)10885403107771(17)220430(10)0001418031 0001418108 (01)10885403107771(17)220430(10)0001418108 0001418415 (01)10885403107771(17)220430(10)0001418415 0001420365 (01)10885403107771(17)220430(10)0001420365 0001421922 (01)10885403107771(17)220630(10)0001421922 0001422603 (01)10885403107771(17)220630(10)0001422603 0001422916 (01)10885403107771(17)220630(10)0001422916 0001423132 (01)10885403107771(17)220630(10)0001423132 0001424769 (01)10885403107771(17)220630(10)0001424769 0001425084 (01)10885403107771(17)220630(10)0001425084 0001426503 (01)10885403107771(17)220630(10)0001426503 0001426326 (01)10885403107771(17)220630(10)0001426326 0001427017 (01)10885403107771(17)220630(10)0001427017 0001427227 (01)10885403107771(17)220630(10)0001427227 0001427711 (01)10885403107771(17)220630(10)0001427711 0001428496 (01)10885403107771(17)220630(10)0001428496 0001429509 (01)10885403107771(17)220630(10)0001429509 0001430610 (01)10885403107771(17)220630(10)0001430610 0001430605 (01)10885403107771(17)220630(10)0001430605 0001431471 (01)10885403107771(17)220630(10)0001431471 0001432426 (01)10885403107771(17)220831(10)0001432426 0001432425 (01)10885403107771(17)220831(10)0001432425 0001433266 (01)10885403107771(17)220831(10)0001433266 0001434250 (01)10885403107771(17)220930(10)0001434250 0001437530 (01)10885403107771(17)221031(10)0001437530
Center Classification Date20220316
Recall Initiation Date20220120
Recalling FirmBard Peripheral Vascular Inc
Initial Notification Letter
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