Drug recall
Guardia Access Embryo Transfer Catheter is used for transferring IVF embryos into the uterine cavity.
FDA recall event 84108 · Class II · Cook Inc.
Key facts
| Event ID | 84108 |
|---|---|
| Recall numbers | Z-0415-2020, Z-0416-2020 |
| Recalling firm | Cook Inc. |
| Product type | Devices |
| Products | Guardia Access Embryo Transfer Catheter is used for transferring IVF embryos into the uterine cavity., Guardia Access Nano Embryo Transfer Catheter is use for transferring IVF embryos into the uterine cavity. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Bent transfer catheter tips may cause difficulty or inability in inserting the transfer catheter into the guiding catheter. Potential adverse events that may occur if an affected product is used… |
| Initiation date | Oct 3, 2019 |
| Report date | Nov 27, 2019 |
| Termination date | May 13, 2020 |
| City | Bloomington |
| State | IN |
| Country | United States |
| FEI number | 1820334 |
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: