Z-0100-2021 Class II Terminated

Recalled by CooperSurgical, Inc. — Trumbull, CT

Recall Details

Product Type
Devices
Report Date
October 21, 2020
Initiation Date
September 8, 2020
Termination Date
January 11, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
531 total boxes

Product Description

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 Pattern

The products were distributed to China.

Code Information

Lot: 20230080