FDAAugust 19, 2015device

Regard Custom Surgical Pack, Item Number: 800628; Sterile, CV0805 - CABG B. Used in cardiovascular surgical procedures.

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

The hazard

Surgical kits contain a surgical scrub product which may be chemically contaminated and lack sterility assurance.

What to do

FDA enforcement status: Terminated

Brands named

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Recall history

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

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