Drug recall
Oxymetry Cable, Rxonly. REF/UDI: HEMOXSC100/(01)00690103196986 - Product Usage: The HemoSphere oximetry cable…
FDA recall event 85409 · Class II · Edwards Lifesciences, LLC
Key facts
| Event ID | 85409 |
|---|---|
| Recall numbers | Z-1928-2020 |
| Recalling firm | Edwards Lifesciences, LLC |
| Product type | Devices |
| Products | Oxymetry Cable, Rxonly. REF/UDI: HEMOXSC100/(01)00690103196986 - Product Usage: The HemoSphere oximetry cable is a multi-use device that connects with a compatible Edwards monitor on one end and any… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Intermittent communication due to inconsistent crimping of connectors onto cables. |
| Initiation date | Oct 7, 2019 |
| Report date | May 20, 2020 |
| Termination date | Apr 27, 2021 |
| 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: