FDASeptember 8, 2020device

MediCult Vitrification Cooling Media, Model Number 12284001F

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

The hazard

There is a discrepancy between the printing on the Product Tyvek label of the individual component packaging. The Chinese characters on the label indicates that it contains an Equilibration Medium (P/N: 12220001) rather than the Vitrification Medium (P/N: 12230001) as indicated on the remainder of the label.

What to do

FDA enforcement status: Terminated

Brands named

coopersurgical

Recall history

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

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MediCult Vitrification Cooling Media, Model Number 12284001F — Recall Details · AllClear