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FDAOctober 16, 2024device

Acrobat-i Vacuum Stabilizer System. Model Number C-OM-10000Z

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

The hazard

Deviations in the manufacturing process created a compromise in the sterile barrier, in which sterility cannot be assured during the duration of the product's 2-year shelf life.

What to do

FDA enforcement status: Ongoing

Brands named

maquet cardiovascularmaquet

UPCs

00607567100008

Recall history

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

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Acrobat-i Vacuum Stabilizer System. Model Number C-OM-10000Z — Recall Details · AllClear