# FDA recall Z-1421-2022

> **CooperSurgical, Inc.** · Class II · device recall initiated 2022-06-13.

## Product

LifeGlobal Fast Freeze Thawing Kit, Model No. GFT5-055

## Reason for recall

There was translation error in the Spanish version of the IFU where the Spanish version instructs the user to leave the blastocyte to air thaw for 5 minutes rather than the correct 5 seconds as indicated in the English version.

## Distribution

Domestic: USA  AL, AZ, CA, CT, FL, GA, ID, IL, IN, KS, MA, MD, MI, MN, MO, MT, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TX, UT, VT, WA, WI,  International:  Belgium, Canada, Croatia, Netherlands, Portugal, Spain

## Key facts

- **Recall number:** Z-1421-2022
- **Recalling firm:** CooperSurgical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-06-13
- **Report date:** 2022-07-27

- **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-1421-2022

## Citation

> AI Analytics. FDA recall Z-1421-2022. Retrieved 2026-08-19 from https://api.ai-analytics.org/recall/Z-1421-2022. Source: US FDA. Licensed CC0.

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