Drug recall
DATEX-OHMEDA AISYS CS2 ALADIN2 CASSETTE Cassettes are intended to be used to deliver anesthetic agent.
FDA recall event 79493 · Class II · GE Healthcare, LLC
Key facts
| Event ID | 79493 |
|---|---|
| Recall numbers | Z-1198-2018, Z-1199-2018 |
| Recalling firm | GE Healthcare, LLC |
| Product type | Devices |
| Products | DATEX-OHMEDA AISYS CS2 ALADIN2 CASSETTE Cassettes are intended to be used to deliver anesthetic agent., DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZER Is designed for the metered delivery of specific inhalation anesthetic agents for use in continuous flow techniques of inhalation anesthesia. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Non-Conforming devices were shipped from the service center without proper evaluation and therefore may be nonconforming. |
| Initiation date | Oct 4, 2017 |
| Report date | Apr 4, 2018 |
| Termination date | Apr 10, 2020 |
| City | Waukesha |
| State | WI |
| Country | United States |
| FEI number | 2126677 |
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: