Recall Z-2703-2014— Vapotherm, Inc.
Class II · Terminated
Class II FDA medical device recall by Vapotherm, Inc., initiated 2014-08-13, terminated 2015-10-02. It names one FDA 510(k) clearance: K072845. 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.
- Recalling firm
- Vapotherm, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-08-13
- Terminated
- 2015-10-02
- Firm location
- Exeter, NH, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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 for recall
Disposable Patient Circuit that allows water to leak into the center gas lumen
Data sourced from openFDA. This site is unofficial and independent of the FDA.