FDA recall Z-0100-2021

Product

MediCult Vitrification Cooling Media, Model Number 12284001F

Reason for recall

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.

Distribution

The products were distributed to China.

Key facts

Status

Terminated

Initiation date

2020-09-08

Report date

2020-10-21

Termination date

2021-01-11

Voluntary/Mandated

Voluntary: Firm initiated

Location

Trumbull, CT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0100-2021