Drug recall
BiPAP A30, Brazil: Continuous ventilator, non-life-supporting. Material Number: BR1111143
FDA recall event 87753 · Class II · Philips Respironics, Inc.
Key facts
| Event ID | 87753 |
|---|---|
| Recall numbers | Z-1625-2021, Z-1626-2021, Z-1627-2021, Z-1628-2021, Z-1629-2021, Z-1630-2021 |
| Recalling firm | Philips Respironics, Inc. |
| Product type | Devices |
| Products | BiPAP A30, Brazil: Continuous ventilator, non-life-supporting. Material Number: BR1111143, BiPAP A40, Brazil: Continuous ventilator, non-life-supporting. Material Number: BR1111169, BiPAP A40, China: Continuous ventilator, non-life-supporting. Material Number - CN1111169, BiPAP A40 System Silver, JP: Continuous ventilator, non-life-supporting. Material Number: 1111177, BiPAP A40 System Silver, JP: Continuous ventilator, non-life-supporting. Material Number: R1111177 and 1 more |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Certain devices were built with motor assemblies that could contain non-conforming plastic material. This could result in 1. Exposure to off-gassing of Volatile Organic Compounds not normally present… |
| Initiation date | Apr 6, 2021 |
| Report date | Jun 2, 2021 |
| Termination date | Jan 17, 2024 |
| City | Murrysville |
| State | PA |
| Country | United States |
| FEI number | 2518422 |
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: