FDA Device recall Z-0100-2021
MediCult Vitrification Cooling Media, Model Number 12284001F
- FDA Device
- Class II
- terminated
- Published 2020-10-21
On 2020-10-21 the FDA classified a Class II recall of MediCult Vitrification Cooling Media, Model Number 12284001F by Coopersurgical, citing 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 Equ….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0100-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-09-08 |
| Published | 2020-10-21 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Coopersurgical |
| Distribution | n/a |
Product
MediCult Vitrification Cooling Media, Model Number 12284001F
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.
Identifiers
| code_info | Lot: 20230080 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
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FDA Device · Class I · 2026-09-30 · Coopersurgical - Endosee System Convenience Kit with IV Tube
FDA Device · Class II · 2025-07-30 · Coopersurgical - Endosee System Convenience Kit
FDA Device · Class II · 2025-07-30 · Coopersurgical - HSG Procedure Tray
FDA Device · Class II · 2025-07-30 · Coopersurgical
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0100-2021%22
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