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CooperSurgical, Inc. recalls MediCult Vitrification Cooling Media, Model Number 12284001F
Recalled October 21, 2020 · FDA recall Z-0100-2021 · CooperSurgical
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. · FDA Class II
Units
531 total boxes
Sold at
The products were distributed to China.
Description
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.
Product
MediCult Vitrification Cooling Media, Model Number 12284001F
Manufacturer(s)
CooperSurgical, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →