Recall Z-2706-2014— 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-NODPC-Low. For use with the Precision Flow system and Ikaria INOmax DSIR ¿ System. This DPC allows clinicians to administer nitric oxide non-invasively via high flow nasal cannula. In the Precision Flow High Flow Therapy application, a special disposable patient circuit re-routes the gas to the INOmax injector module then back into the Precision Flow system. Reason: Water may leak into the center gas lumen of the Patient Circuit.
- 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-NODPC-Low. For use with the Precision Flow system and Ikaria INOmax DSIR ¿ System. This DPC allows clinicians to administer nitric oxide non-invasively via high flow nasal cannula. In the Precision Flow High Flow Therapy application, a special disposable patient circuit re-routes the gas to the INOmax injector module then back into the Precision Flow system
Reason for recall
Water may leak into the center gas lumen of the Patient Circuit
Data sourced from openFDA. This site is unofficial and independent of the FDA.