Drug recall
EZ Glide Aortic Cannula, 24 Fr. (8.0mm) x 37.6 cm (14.8") 3/8" (9.5 mm) vented connector, RX Only, Sterile…
FDA recall event 84065 · Class II · Edwards Lifesciences, LLC
Key facts
| Event ID | 84065 |
|---|---|
| Recall numbers | Z-0420-2020 |
| Recalling firm | Edwards Lifesciences, LLC |
| Product type | Devices |
| Products | EZ Glide Aortic Cannula, 24 Fr. (8.0mm) x 37.6 cm (14.8") 3/8" (9.5 mm) vented connector , RX Only, Sterile EC, Made in Mexico, UDI: 00690103172119 for the following REF #s (UDI): EZC21A… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Their is a possibility that the cannula may separate from its connector, potentially causing a breach of circuit during cardiopulmonary bypass which could result in significant blood loss. |
| Initiation date | Oct 22, 2019 |
| Report date | Nov 27, 2019 |
| Termination date | Jun 29, 2022 |
| City | Irvine |
| State | CA |
| Country | United States |
| FEI number | 2015691 |
At a glance
- 1–9 Products in this recall
- None 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: