FDA-Device2022-07-27Class II
LifeGlobal Fast Freeze Thawing Kit, Model No. GFT5-055
CooperSurgical, Inc.
Hazard
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.
Sold states
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
Affected count
403 units
Manufactured in
95 Corporate Dr, N/A, Trumbull, CT, United States
Products
LifeGlobal Fast Freeze Thawing Kit, Model No. GFT5-055
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1421-2022Don't want to check this manually?
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