FDA Device recall Z-2703-2014
Vapotherm Precision Flow,Disposable Patient Circuit PF-DPC-Low
- FDA Device
- Class II
- terminated
- Published 2014-10-01
On 2014-10-01 the FDA classified a Class II recall of Vapotherm Precision Flow,Disposable Patient Circuit PF-DPC-Low by Vapotherm, citing disposable Patient Circuit that allows water to leak into the center gas lumen.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2703-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-08-13 |
| Published | 2014-10-01 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Vapotherm |
| Distribution | US |
Product
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 source for administration to a neonate/infant, pediatric and adult patients in the hospital, sub-acute institutions, and home settings. It adds heat and moisture to blended medical air/oxygen mixture and assures the integrity of the precise air/oxygen mixture via an integral oxygen analyzer. The flow rates may be from 1 to 40 liters per minute via nasal cannula.
Reason
Disposable Patient Circuit that allows water to leak into the center gas lumen
Identifiers
| code_info | Lot Numbers 1402021 through 1406010, excluding lots 1402024 through 1402028 and 1404003. These numbers are applicable r…Lot Numbers 1402021 through 1406010, excluding lots 1402024 through 1402028 and 1404003. These numbers are applicable regardless of the prefix preceding them (i.e. HF, HFE, HFH, HFN, LF, LFE, LFH or LFN). |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2703-2014%22
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