FDAOctober 25, 2019device

BARD MAX-CORE Disposable Core Biopsy Instrument - Product Usage: The core needle biopsy device is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lymph nodes and various soft tissue tumors. It is not intended for use in bone.

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

The hazard

During the firm's review of May 2019 complaint data, a significant increase in Disposable Core Biopsy Instrument complaints were observed for Failure to Fire, Firing Problem, and Failure to Obtain Samples.

What to do

FDA enforcement status: Terminated

Brands named

bard peripheral vascularbardbard peripheral

UPCs

00801741084423008017410844300080174108444700801741084454008017410844610080174108447800801741084485008017410844920080174108451500801741084522

Recall history

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

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