FDAJune 16, 2022device

Various Angiography/Cath Lab packs/trays

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

The hazard

Product was exposed to multiple sterilization cycles without validation for multiple exposures.

What to do

FDA enforcement status: Ongoing

Brands named

american contract systemsamericanamerican contract

UPCs

441113930052614854252004274413169800528149944910042964071585006304423519200531641099740063244234510005336420938300634442287050053544228708005364421915100537

Recall history

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

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