LifeGlobal Fast Freeze Thawing Kit, Model No. GFT5-055
Reported: July 27, 2022 Initiated: June 13, 2022 #Z-1421-2022
Product Description
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.
Details
- Recalling Firm
- CooperSurgical, Inc.
- Units Affected
- 403 units
- 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
- Location
- Trumbull, CT
Frequently Asked Questions
What product was recalled? ▼
LifeGlobal Fast Freeze Thawing Kit, Model No. GFT5-055. Recalled by CooperSurgical, Inc.. Units affected: 403 units.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 27, 2022. Severity: Moderate. Recall number: Z-1421-2022.
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