Drug recall
Vapotherm Precision Flow, Disposable Patient Circuit PF-DPC-High. For use with the Precision Flow system…
FDA recall event 69116 · Class II · Vapotherm, Inc.
Key facts
| Event ID | 69116 |
|---|---|
| Recall numbers | Z-2699-2014, Z-2700-2014, Z-2701-2014, Z-2702-2014, Z-2703-2014, Z-2704-2014, Z-2705-2014, Z-2706-2014 |
| Recalling firm | Vapotherm, Inc. |
| Product type | Devices |
| Products | Vapotherm Precision Flow, Disposable Patient Circuit PF-DPC-High. For use with the Precision Flow system Precision Flow" is intended for use to add warm moisture to breathing gases from an external…, Vapotherm Precision Flow,Disposable Patient Circuit PF-DPC-Low. For use with the Precision Flow system Precision Flow" is intended for use to add warm moisture to breathing gases from an external…, Vapotherm Precision Flow,Disposable Patient Circuit PF-E-DPC-High. For use with the Precision Flow system Precision Flow" is intended for use to add warm moisture to breathing gases from an external…, Vapotherm Precision Flow,Disposable Patient Circuit PF-E-DPC-Low. PF-DPC-Low packaged with compatible cannulas for evaluation of the Precision Flow system, Vapotherm Precision Flow,Disposable Patient Circuit PFH-DPC-High. For use with the Heliox Precision Flow system Precision Flow" is intended for use to add warm moisture to breathing gases from an… and 3 more |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Disposable Patient Circuit that allows water to leak into the center gas lumen, Water may leak into the center gas lumen of the Patient Circuit |
| Initiation date | Aug 13, 2014 |
| Report date | Oct 1, 2014 |
| Termination date | Oct 2, 2015 |
| City | Exeter |
| State | NH |
| Country | United States |
| FEI number | 3010503671 |
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: