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

Bard Peripheral Vascular Inc: ADULT LUMBAR PUNCTURE DRUG FREE TRAY 20G

Is my product affected?

ADULT LUMBAR PUNCTURE DRUG FREE TRAY 20G

  • UPC 10885403231810

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

What happened

Bard Peripheral Vascular Inc. is recalling 1,260 Adult Lumbar Puncture Drug Free Trays (20G, Catalog Number 4301CDF) due to manometer failure modes involving leaking and mating issues. The affected devices were distributed nationwide across the United States, Puerto Rico, and internationally to Costa Rica and Hong Kong. The recalled lot numbers are 0001433537 and 0001437269.

The source document does not specify a remedy for consumers who have obtained this 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: 1260 devices Lot/code info: Catalog Number: 4301CDF Lot Numbers/UDI (GTIN, DI + PI): 0001433537 (01)10885403231810(17)260831(10)0001433537 0001437269 (01)10885403231810(17)260930(10)0001437269

Source

Official record: FDA (Device enforcement) ↗

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

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