Drug recall
Servo-i Ventilator, Part No. 6487800, UDI Code 07325710000823 - Product Usage: intended for general and…
FDA recall event 86548 · Class II · Getinge Group Logistics America, LLC
Key facts
| Event ID | 86548 |
|---|---|
| Recall numbers | Z-0092-2021 |
| Recalling firm | Getinge Group Logistics America, LLC |
| Product type | Devices |
| Products | Servo-i Ventilator, Part No. 6487800, UDI Code 07325710000823 - Product Usage: intended for general and critical ventilator care, and it can be used for low end to high end intensive care, in… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | A potentially shorter than specified nebulizer connector may result in difficulty in installing the Aeroneb Nebulizer module to the Servo-i device successfully. |
| Initiation date | Sep 17, 2020 |
| Report date | Oct 21, 2020 |
| City | Wayne |
| State | NJ |
| Country | United States |
| FEI number | 3012092534 |
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: