Bard Peripheral Vascular Inc Recall 89553
Description: SAFE-T PLUS ATRAUMATIC ADULT LP TRAY
Bard Peripheral Vascular Inc Recall 89553 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0800-2022 |
| Event ID | 89553 |
| Event Description | SAFE-T PLUS ATRAUMATIC ADULT LP TRAY |
| 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 | 3,240 devices |
| Recall Reason | Due to lumbar puncture tray manometer failure mode of leaking and mating issues. |
| Device Classification | 20220323 |
| Device Code Info | 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 |
| Center Classification Date | 20220316 |
| Recall Initiation Date | 20220120 |
| Recalling Firm | Bard Peripheral Vascular Inc |
| Initial Notification | Letter |
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