Reported Jul 27, 2022 · Ongoing

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

CooperSurgical, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: CooperSurgical, Inc. · 95 Corporate Dr · Trumbull, CT · 06611-1350

Is this the product you have?

  • LifeGlobal Fast Freeze Thawing Kit, Model No. GFT5-055
Lot codes and dates
  • UDI(01)00815965020914 (17)220819 (10)GFT5-200218U (01)00815965020914 (17)220819 (10)GFT5-201026U (01)00815965020914 (17)220819 (10)GFT5-21335060
  • Lots
    • 21335060
    • GFT5-200218U
    • GFT5-201026U
Amount recalled
403 units

Where it was sold

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:22 PM UTC

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