Recall Z-0100-2021 ยท MQL Media, Reproductive
CooperSurgical, Inc.
MediCult Vitrification Cooling Media, Model Number 12284001F
| Date | Sep 8, 2020 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Under Investigation by firm |
| Action | URGENT: MEDICAL DEVICE FIELD SAFETY NOTICE letters dated 9/8/20 were sent to customers. Our records indicate that you have purchased the affected Product from CooperSurgical. The affected Vitrification Medium Product is of the correct formulation and functionally acceptable per quality release specifications and will work as intended in accordance with the accompanying Instructions For Use. Please discontinue use of and quarantine the Products, complete the attached Acknowledgement and Receipt Form, and return it to CooperSurgical. Once we receive the Acknowledgement Form, we will arrange fo |
| Quantity | 531 total boxes |
| Distribution | The products were distributed to China. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K100367 | MEDICULT VITRIFICATION COOLING/WARMING, MODEL REF: 1228, 1229 Origio A/S, Aug 27, 2010 |