Home / Recalls / Vapotherm, Inc. / Z-2706-2014

Z-2706-2014 Class II Terminated

Recalled by Vapotherm, Inc. — Exeter, NH

Recall Details

Product Type
Devices
Report Date
October 1, 2014
Initiation Date
August 13, 2014
Termination Date
October 2, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
207 units

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

Distribution Pattern

Worldwide Distribution - USA (nationwide) and Internationally to Canada, France, Swizerland, Korea, Sweden, Germany , Belgium, Spain, Mexico, Scotland, UAE, Australia, Israel, Hong Kong, Ireland, kuwait, and Italy.

Code Information

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).

Other recalls by Vapotherm, Inc.

  • Z-1272-2023 Class II — Low Flow Disposable Patient Circuit for the Precision Flow System, Product Code (December 16, 2022)
  • Z-2700-2014 Class II — Vapotherm Precision Flow,Disposable Patient Circuit PF-E-DPC-High. For use with (August 13, 2014)
  • Z-2704-2014 Class II — Vapotherm Precision Flow,Disposable Patient Circuit PF-E-DPC-Low. PF-DPC-Low p (August 13, 2014)
  • Z-2701-2014 Class II — Vapotherm Precision Flow,Disposable Patient Circuit PFH-DPC-High. For use with (August 13, 2014)
  • Z-2699-2014 Class II — Vapotherm Precision Flow, Disposable Patient Circuit PF-DPC-High. For use with (August 13, 2014)
  • Z-2705-2014 Class II — Vapotherm Precision Flow,Disposable Patient Circuit PFHDPC-Low. For use with (August 13, 2014)
  • Z-2703-2014 Class II — Vapotherm Precision Flow,Disposable Patient Circuit PF-DPC-Low. For use with t (August 13, 2014)
  • Z-2702-2014 Class II — Vapotherm Precision Flow,Disposable Patient Circuit PFNODPC-High. For use with (August 13, 2014)