# FDA recall Z-0100-2021

> **CooperSurgical, Inc.** · Class II · device recall initiated 2020-09-08.

## 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

- **Recall number:** Z-0100-2021
- **Recalling firm:** CooperSurgical, Inc.
- **Classification:** Class II
- **Product type:** device
- **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

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

## Citation

> AI Analytics. FDA recall Z-0100-2021. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0100-2021. Source: US FDA. Licensed CC0.

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