FDASeptember 30, 2024device

Bard Marquee Disposable Core Biopsy Instrument Kit: BARD MARQUEE KIT 12G X 10 CM, REF: MQK1210; BARD MARQUEE 12G X 10 CM, REF: MQ1210; BARD MARQUEE Kit 12G X 13 CM, REF: MQK1213; BARD MARQUEE 12G X 13 CM, REF: MQ1213

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Disposable biopsy instruments were potentially manufactured missing the backend notch retention feature on the needle that results in inadequate securing of the needle inside the device, which could lead to needle detachment and misplacement, which could lead to tissue damage and bleeding.

What to do

FDA enforcement status: Ongoing

Brands named

bard peripheral vascularbardbard peripheral

UPCs

00801741097263008017410971190080174109727000801741097126

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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