Recall Z-0797-2022 ยท PWY Lumbar Puncture Tray (Adult & Pediatric)
Bard Peripheral Vascular Inc
SAFE-T PLUS LUMBARPUNCTURE TRAY ADULT
| Date | Jan 20, 2022 |
| Status | Open, Classified |
| Reason | Due to lumbar puncture tray manometer failure mode of leaking and mating issues. |
| Root cause | Process control |
| Action | Between 01/28 and 02/01/2022, the firm sent an "URGENT MEDICAL DEVICE CORRECTION" Letter via email and FedEx 2-day mailings to customers informing them that between 07/02 to 12/15/2021 the firm received 59 customer complaints for lumbar puncture tray manometers with reported failure modes of leaking and mating issues. Customers are asked to take the following actions: 1. Check all inventory locations within their institution for the product listed in Table A and immediately destroy all affected product remaining in their possession. The product should have the sterile barrier broken and destr |
| Quantity | 15,650 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 K |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.