Bard Peripheral Vascular Inc: SAFE-T PLUS LUMBARPUNCTURE TRAY ADULT

Is my product affected?

SAFE-T PLUS LUMBARPUNCTURE TRAY ADULT

• UPC 10885403107795

Check against the official notice below — it lists the full affected range.

What happened

Bard Peripheral Vascular Inc. is recalling 15,650 SAFE-T PLUS Lumbar Puncture Trays for Adults due to manometer failure, specifically problems with leaking and mating issues. The affected trays have Catalog Number 4306CSP and were distributed nationwide across all U.S. states, Puerto Rico, Costa Rica, and Hong Kong, with specific lot numbers ranging from 0001410708 through 0001437662.

The recall record does not specify a remedy or corrective action for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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

Details from the source

Reason for recall: Due to lumbar puncture tray manometer failure mode of leaking and mating issues. 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: 15,650 devices Lot/code info: Catalog Number: 4306CSP Lot Numbers/UDI (GTIN, DI + PI): 0001410708 (01)10885403107795(17)220331(10)0001410708 0001411191 (01)10885403107795(17)220331(10)0001411191 0001412491 (01)10885403107795(17)220331(10)0001412491 0001413309 (01)10885403107795(17)220331(10)0001413309 0001416352 (01)10885403107795(17)220430(10)0001416352 0001417049 (01)10885403107795(17)220430(10)0001417049 0001420356 (01)10885403107795(17)220430(10)0001420356 0001421923 (01)10885403107795(17)220630(10)0001421923 0001422376 (01)10885403107795(17)220630(10)0001422376 0001425371 (01)10885403107795(17)220630(10)0001425371 0001426677 (01)10885403107795(17)220630(10)0001426677 0001429128 (01)10885403107795(17)220630(10)0001429128 0001432172 (01)10885403107795(17)220630(10)0001432172 0001433264 (01)10885403107795(17)220831(10)0001433264 0001433845 (01)10885403107795(17)220930(10)0001433845 0001437662 (01)10885403107795(17)221031(10)0001437662

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

Related recalls

• Safe-T PLUS Pediatric/Infant Lumbar Puncture Tray, 22 g x 1.5" Spinal Needle with Manometer2022-01-20
• LUMBAR PUNCTURE TRAY PEDIATRIC 21G 2.52022-01-20
• LUMBAR PUNCTURE TRAY ADULT 20G X 3.5 DP2022-01-20
• ADULT LUMBAR PUNCTURE DRUG FREE TRAY 20G2022-01-20
• SAFE-T PLUS LUMBAR PUNCTURE TRAY ADULT2022-01-20

All FDA (Device enforcement) recalls