FDAMay 2, 2019device

EnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5 pouches/carton, single use, Rx, catalog/REF number 7G - REF ECP017G.Product Usage: Indicated for use in acquiring tissue for diagnosing breast abnormalities.

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

The hazard

There has been an increase in complaints related to leaks, suction issues, and failure to obtain samples while using the product.

What to do

FDA enforcement status: Terminated

Brands named

bard peripheral vascularbardbard peripheral

Recall history

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

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