Bard Peripheral Vascular Inc: LUMBAR PUNCTURE TRAY PEDIATRIC 21G 2.5

Is my product affected?

LUMBAR PUNCTURE TRAY PEDIATRIC 21G 2.5

• UPC 10885403057052

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

What happened

Bard Peripheral Vascular Inc is recalling approximately 11,970 Pediatric 21G 2.5 Lumbar Puncture Trays (Catalog Number 4304C) due to manometer failure issues involving leaking and mating problems. The recalled trays were distributed nationwide throughout the United States, Puerto Rico, and internationally to Costa Rica and Hong Kong, with multiple lot numbers distributed between March 2022 and October 2022.

The source document does not specify a remedy for consumers who may have the recalled product.

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: 11,970 devices Lot/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

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 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