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
21335060GFT5-200218UGFT5-201026U
- 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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