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FDAJune 3, 2024device

Bottle Decanter, REF 2004S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 products to a case (cs).

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

The hazard

During sterile barrier testing performed on the decanter product line, the samples were identified to have pin holes and tears in the packaging film.

What to do

FDA enforcement status: Ongoing

Brands named

microtek medicalmicrotek

UPCs

00748426002498

Recall history

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

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Bottle Decanter, REF 2004S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 products to a case (cs). — Recall Details · AllClear