Bard Peripheral Vascular Inc: LUMBAR PUNCTURE TRAY ADULT 22G X3.5 STRL

Is my product affected?

LUMBAR PUNCTURE TRAY ADULT 22G X3.5 STRL

• UPC 10885403057069

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

What happened

Bard Peripheral Vascular Inc. has recalled 29,870 Lumbar Puncture Tray Adult 22G X3.5 Strl devices (Catalog Number 4306C) due to manometer failure involving leaking and mating issues. The affected devices were distributed nationwide across all U.S. states, Washington D.C., Puerto Rico, Costa Rica, and Hong Kong, with specific lot numbers and UDI codes identified for the recalled units.

The recall source does not specify what actions affected consumers should take in response to this recall.

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: 29,870 devices Lot/code info: Catalog Number: 4306C Lot Numbers/UDI (GTIN, DI + PI): 0001410709 (01)10885403057069(17)220331(10)0001410709 0001411249 (01)10885403057069(17)220331(10)0001411249 0001412995 (01)10885403057069(17)220331(10)0001412995 0001414260 (01)10885403057069(17)220331(10)0001414260 0001414360 (01)10885403057069(17)220430(10)0001414360 0001415852 (01)10885403057069(17)220331(10)0001415852 0001417193 (01)10885403057069(17)220430(10)0001417193 0001415027 (01)10885403057069(17)220430(10)0001415027 0001419336 (01)10885403057069(17)220430(10)0001419336 0001422223 (01)10885403057069(17)220630(10)0001422223 0001425520 (01)10885403057069(17)220630(10)0001425520 0001426674 (01)10885403057069(17)220630(10)0001426674 0001428621 (01)10885403057069(17)220630(10)0001428621 0001429518 (01)10885403057069(17)220630(10)0001429518 0001430118 (01)10885403057069(17)220630(10)0001430118 0001433265 (01)10885403057069(17)220831(10)0001433265 0001433844 (01)10885403057069(17)220930(10)0001433844 0001434817 (01)10885403057069(17)220930(10)0001434817 0001438147 (01)10885403057069(17)221031(10)0001438147

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