Drug recall
Low Flow Disposable Patient Circuit for the Precision Flow System, Product Code PF-DPC-LOW
FDA recall event 91579 · Class II · Vapotherm
Key facts
| Event ID | 91579 |
|---|---|
| Recall numbers | Z-1272-2023 |
| Recalling firm | Vapotherm |
| Product type | Devices |
| Products | Low Flow Disposable Patient Circuit for the Precision Flow System, Product Code PF-DPC-LOW |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | There have been reports of excessive condensation associated with certain lots of the Low Flow Disposable Patient Circuits (DPCs) used with Precision Flow System which may lead to excessive rainout. |
| Initiation date | Dec 16, 2022 |
| Report date | Mar 29, 2023 |
| City | Exeter |
| State | NH |
| Country | United States |
| FEI number | 3012971441 |
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: