Z-1421-2022 Class II Ongoing
FDA device recall Z-1421-2022 was initiated by CooperSurgical, Inc. on Jun 13, 2022 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 403 units.
Recall Details
- Product Type
- Devices
- Report Date
- Jul 27, 2022
- Initiation Date
- Jun 13, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 403 units
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.
Distribution Pattern
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
Code Information
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1421-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026