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FDA (Device enforcement)Recalled 2022-01-20class ii

Bard Peripheral Vascular Inc: ATRAUMATIC ADULT LUMBAR PUNCTURE TRAY

Is my product affected?

ATRAUMATIC ADULT LUMBAR PUNCTURE TRAY

  • UPC 10885403228995

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

What happened

Bard Peripheral Vascular Inc. is recalling 2,880 Atraumatic Adult Lumbar Puncture Trays due to manometer failure modes involving leaking and mating issues. The affected trays were distributed nationwide across the United States, as well as to Costa Rica and Hong Kong. The recalled devices are identified by Catalog Number 4306CW with specific lot numbers ranging from 0001415028 through 0001436376.

The recall notice does not specify a remedy or corrective action for consumers who possess these devices.

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: 2,880 devices Lot/code info: Catalog Number: 4306CW Lot Numbers/UDI (GTIN, DI + PI): 0001415028 (01)10885403228995(17)220430(10)0001415028 0001417842 (01)10885403228995(17)220430(10)0001417842 0001424355 (01)10885403228995(17)220630(10)0001424355 0001431413 (01)10885403228995(17)220630(10)0001431413 0001436376 (01)10885403228995(17)220930(10)0001436376

Source

Official record: FDA (Device enforcement) ↗

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

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