Drug recall
EVair 03 (Jun-air) air compressor, model numbers: 1609000 and 1609002
FDA recall event 93715 · Class I · Datex-Ohmeda, Inc.
Key facts
| Event ID | 93715 |
|---|---|
| Recall numbers | Z-0774-2024, Z-0775-2024, Z-0776-2024 |
| Recalling firm | Datex-Ohmeda, Inc. |
| Product type | Devices |
| Products | EVair 03 (Jun-air) air compressor, model numbers: 1609000 and 1609002, EVair air compressor, model numbers: M1230849 and M1230847, EvAir CPRSR Kit Upgrade: a) DISS/CEE 7/7 230V 50/60 HZ, Model Number M1230849; b) DISS/NEMA 5-15 115V 60 HZ, Model Number M1230847; c) NIST/BS 1363 230V 50/60 HZ, Model Number M1230849; d) NIST/BS 546… |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | GE HealthCare has become aware of elevated levels of formaldehyde when the EVair or EVair 03 (Jun-Air) optional compressors are used with the CARESCAPE R860 or Engstr¿m Carestation/Pro ventilators… |
| Initiation date | Dec 29, 2023 |
| Report date | Feb 7, 2024 |
| City | Madison |
| State | WI |
| Country | United States |
| FEI number | 2112667 |
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: