FDAJune 16, 2022device

Various Pacemaker Packs, Cardio Thoracic Packs

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

639871160067441236930058639568810069148580030041044132805005114412954100512641107410061344314505005144431450400515443157780051644313827005176420475400618

Recall history

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

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Various Pacemaker Packs, Cardio Thoracic Packs — Recall Details · AllClear