Bard Peripheral Vascular Inc: Safe-T PLUS Pediatric/Infant Lumbar Puncture Tray, 22 g x 1.5" Spinal Needle with Manometer

Is my product affected?

Safe-T PLUS Pediatric/Infant Lumbar Puncture Tray, 22 g x 1.5" Spinal Needle with Manometer

• UPC 10885403107788

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

What happened

Bard Peripheral Vascular Inc. has recalled 20,400 units of the Safe-T PLUS Pediatric/Infant Lumbar Puncture Tray with 22 g x 1.5" spinal needle due to manometer failure. The manometer can leak and experience mating issues that could affect its function. The affected trays were distributed nationwide across the United States, Puerto Rico, and internationally to Costa Rica and Hong Kong.

The recalled product has catalog number 4302CSP with multiple lot numbers dated from March through October 2022. The source does not specify a remedy 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: 20,400 devices Lot/code info: Catalog Number: 4302CSP Lot Numbers/UDI (GTIN, DI + PI): 0001412493 (01)10885403107788(17)220331(10)0001412493 0001415324 (01)10885403107788(17)220430(10)0001415324 0001416351 (01)10885403107788(17)220430(10)0001416351 0001417052 (01)10885403107788(17)220430(10)0001417052 0001417550 (01)10885403107788(17)220430(10)0001417550 0001421010 (01)10885403107788(17)220531(10)0001421010 0001422378 (01)10885403107788(17)220630(10)0001422378 0001425085 (01)10885403107788(17)220630(10)0001425085 0001426188 (01)10885403107788(17)220630(10)0001426188 0001426941 (01)10885403107788(17)220630(10)0001426941 0001428873 (01)10885403107788(17)220630(10)0001428873 0001431044 (01)10885403107788(17)220630(10)0001431044 0001433024 (01)10885403107788(17)220831(10)0001433024 0001433846 (01)10885403107788(17)220930(10)0001433846 0001437468 (01)10885403107788(17)221031(10)0001437468 0001438331 (01)10885403107788(17)221031(10)0001438331 0001439310 (01)10885403107788(17)221031(10)0001439310 0001440531 (01)10885403107788(17)221031(10)0001440531

Source

Official record: FDA (Device enforcement) ↗

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

Related recalls

• 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
• LUMBAR PUNCTURE TRAY ADULT 18G X 3.52022-01-20

All FDA (Device enforcement) recalls