FDANovember 8, 2023device

Bard Mission Disposable Core Biopsy Instrument Kit (REF/Name): 1410MSK/ Mission Kit 14G x 10CM; 1416MSK/ Mission Kit 14G x 16CM; 1610MSK/ Mission Kit 16G x 10CM; 1616MSK/ Mission Kit 16G x 16CM; 1810MSK/ Mission Kit 18G x 10CM; 1816MSK/ Mission Kit 18G x 16CM; 1820MSK/ Mission Kit 18G x 20CM; 182...

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

The hazard

The internal diameter of the coaxial cannula may be smaller or larger than the external diameter of the biopsy needle, and the length of the cannula may exceed the stated length on the label. As a result, the biopsy needle may not fit properly into the coaxial cannula, preventing access to the target tissue, which could lead to tissue injury, longer and repeat procedures.

What to do

FDA enforcement status: Ongoing

Brands named

bard peripheral vascularbardbard peripheral

UPCs

0080174114254300801741142550008017411425670080174114257400801741097058008017410970650080174109707200801741142581008017410970890080174109709600801741097102

Recall history

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

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