Recall Z-2704-2014— Vapotherm, Inc.

Name: FDA recall Z-2704-2014
Creator: U.S. Food and Drug Administration
Published: 2014-08-13

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-E-DPC-Low. PF-DPC-Low packaged with compatible cannulas for evaluation of the Precision Flow system. 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 record

K072845 — PRECISION FLOWVapotherm, Inc.·cleared 2008-07-17

K-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-E-DPC-Low. PF-DPC-Low packaged with compatible cannulas for evaluation of the Precision Flow system

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.