Home / Recalls / Vapotherm, Inc. / Z-2702-2014

Z-2702-2014 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
387 units

Product Description

Vapotherm Precision Flow,Disposable Patient Circuit PFNODPC-High. 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 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

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-2706-2014 Class II — Vapotherm Precision Flow,Disposable Patient Circuit PF-NODPC-Low. For use wi (August 13, 2014)