Drug recall
LifeGlobal Fast Freeze Thawing Kit, Model No. GFT5-055
FDA recall event 90469 · Class II · CooperSurgical, Inc.
Key facts
| Event ID | 90469 |
|---|---|
| Recall numbers | Z-1421-2022 |
| Recalling firm | CooperSurgical, Inc. |
| Product type | Devices |
| Products | LifeGlobal Fast Freeze Thawing Kit, Model No. GFT5-055 |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Jun 13, 2022 |
| Report date | Jul 27, 2022 |
| City | Trumbull |
| State | CT |
| Country | United States |
| FEI number | 1216677 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: