FDAAugust 7, 2015device

IBC Aortic Punch Catalog Numbers APM40, APL48A, APM44A, APL40A, APM40A, CVAPL36, CVAPL40, CVAPL44, CVAPL48, CVAPL52, APM28BM, APM36BM, APM40BM, APM44BM, APM48BM, APM40BK, APM48BK, APM36BK, APM44BK, APM28, APM36, APL44, APM40 Product Usage: The IBC Aortic Punch is a single-use, disposable surgical...

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

The hazard

It was discovered that the heat seal placed onto sterile pouches may not meet strength acceptance criteria.

What to do

FDA enforcement status: Terminated

Brands named

international biophysicsinternational

Recall history

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

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