CLASS II ONGOING Device recall · Reported 27 Jul 2022 · FDA Enforcement Report
LifeGlobal Fast Freeze Thawing Kit recalled by CooperSurgical
CooperSurgical is recalling LifeGlobal Fast Freeze Thawing Kit, distributed in 31 states. The recall was initiated on 13 Jun 2022 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1421-2022
- FDA event ID
- 90469
- Recalling firm
- CooperSurgical, Trumbull, CT
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 13 Jun 2022
- FDA classified
- 20 Jul 2022
- Reported
- 27 Jul 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- N/A
- Reason category
- Temperature Abuse
- Device type
- Other Medical Devices
Timeline
| 13 Jun 2022 | Recall initiated by company | |
| 20 Jul 2022 | Classified by FDA | +37 days |
| 27 Jul 2022 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Foods that need refrigeration and were stored or shipped too warm can grow harmful bacteria without any change in look or smell.
Product as listed by the FDA
LifeGlobal Fast Freeze Thawing Kit, Model No. GFT5-055
Where it was distributed
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
AlabamaArizonaCaliforniaConnecticutFloridaGeorgiaIdahoIllinoisIndianaKansasMassachusettsMarylandMichiganMinnesotaMissouriMontanaNorth CarolinaNebraskaNew JerseyNevada
Questions about this recall
Why was it 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 lots are affected?
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
Where was it sold?
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
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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