Drug recall
EtCO2 Module -Part Number: 02.01.210699 Monitors: iM80, iM50, M50, iM70, iM60, iM8, iM8A, iM8B Patient…
FDA recall event 74632 · Class II · Edan Diagnostics
Key facts
| Event ID | 74632 |
|---|---|
| Recall numbers | Z-2388-2016 |
| Recalling firm | Edan Diagnostics |
| Product type | Devices |
| Products | EtCO2 Module -Part Number: 02.01.210699 Monitors: iM80, iM50, M50, iM70, iM60, iM8, iM8A, iM8B Patient Monitors and iM60 Vet, iM70 Vet Veterinary Monitors EtCO2 module is an optional component of the… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Incorrect CO2 readings with some patient monitors. |
| Initiation date | Jun 23, 2016 |
| Report date | Aug 17, 2016 |
| Termination date | Nov 16, 2016 |
| City | San Diego |
| State | CA |
| Country | United States |
| FEI number | 3009499478 |
At a glance
- 1–9 Products in this recall
- 1–9 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: