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CooperSurgical, Inc. Recall 90469

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

CooperSurgical, Inc. Recall 90469 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-1421-2022
Event ID90469
Event DescriptionLifeGlobal Fast Freeze Thawing Kit, Model No. GFT5-055
Product TypeDevices
DistributionDomestic: 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
Quantity403 units
Recall ReasonThere 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.
Device Classification20220727
Device Code InfoUDI: (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
Center Classification Date20220720
Recall Initiation Date20220613
Recalling FirmCooperSurgical, Inc.
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