Z-1421-2022Class II

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

Name: Z-1421-2022 LifeGlobal Fast Freeze Thawing Kit, Model No. GFT5-055
Creator: CooperSurgical, Inc.
Published: 2022-06-13
License: https://open.fda.gov/license/

CooperSurgical, Inc. / initiated 2022-06-13 / Open, Classified / root cause: labeling and UDI

FDA source

CooperSurgical, Inc. began a recall of LifeGlobal Fast Freeze Thawing Kit, Model No. GFT5-055 on 2022-06-13. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1421-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-06-13
Posted: 2022-07-20
Recalling firm: CooperSurgical, Inc.
Product: LifeGlobal Fast Freeze Thawing Kit, Model No. GFT5-055
Product code: MQL Media, Reproductive
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.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: On June 13, 2022, the firm distributed Urgent Media Safety Notice letters to affected customers. Customers were informed that setting out a thawing blastocyte for 5 minutes may be detrimental to the survival of the blastocyte. Customers were asked to complete and return an acknowledgement form. Once the firm has received the completed form, they will provide the corrected IFU.
Quantity in commerce: 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
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1421-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1421-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-07-27	2022-07-20

Product code MQL

K092963Class IIGlobal Blastocyst Vitrification Kit & Vitrification Thawing Kit - Based on S3Genx Intl., Inc. / cleared 2011-01-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)