Bard Peripheral Vascular Inc Recall 89553
Description: LUMBAR PUNCTURE TRAY PEDIATRIC 21G 2.5
Bard Peripheral Vascular Inc Recall 89553 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0791-2022 |
| Event ID | 89553 |
| Event Description | LUMBAR PUNCTURE TRAY PEDIATRIC 21G 2.5 |
| Product Type | Devices |
| 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. |
| Quantity | 11,970 devices |
| Recall Reason | Due to lumbar puncture tray manometer failure mode of leaking and mating issues. |
| Device Classification | 20220323 |
| Device Code Info | Catalog Number: 4304C Lot Numbers/UDI (GTIN, DI + PI): 0001414261 (01)10885403057052(17)220331(10)0001414261 0001414362 (01)10885403057052(17)220430(10)0001414362 0001415851 (01)10885403057052(17)220430(10)0001415851 0001415026 (01)10885403057052(17)220430(10)0001415026 0001421686 (01)10885403057052(17)220630(10)0001421686 0001424759 (01)10885403057052(17)220630(10)0001424759 0001426324 (01)10885403057052(17)220630(10)0001426324 0001428876 (01)10885403057052(17)220630(10)0001428876 0001432173 (01)10885403057052(17)220630(10)0001432173 0001434168 (01)10885403057052(17)220930(10)0001434168 0001438149 (01)10885403057052(17)221031(10)0001438149 0001438930 (01)10885403057052(17)221031(10)0001438930 0001441010 (01)10885403057052(17)221031(10)0001441010 |
| Center Classification Date | 20220316 |
| Recall Initiation Date | 20220120 |
| Recalling Firm | Bard Peripheral Vascular Inc |
| Initial Notification | Letter |
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