FDA-Device2020-10-21Class II
MediCult Vitrification Cooling Media, Model Number 12284001F
CooperSurgical, Inc.
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.
Sold states
The products were distributed to China.
Affected count
531 total boxes
Manufactured in
95 Corporate Dr, N/A, Trumbull, CT, United States
Products
MediCult Vitrification Cooling Media, Model Number 12284001F
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0100-2021Don't want to check this manually?
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