The Recall Desk

FDA (Devices) recall action 69116

Vapotherm, Inc. recalled 8 products on 2014-10-01

The FDA (Devices) publishes a recall like this one as 8 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 8 pages.

Products
8
Announced
2014-10-01
Critical
0
Units
48,329

Why these products were recalled

Disposable Patient Circuit that allows water to leak into the center gas lumen

Water may leak into the center gas lumen of the Patient Circuit

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–8 of 8

  • HighFDA (Devices)··2014-10-01

    Vapotherm Precision Flow Disposable Patient Circuit Recalled for Water Leakage

    Vapotherm is recalling 22,042 Precision Flow Disposable Patient Circuits because they may allow water to leak into the center gas lumen.

    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…
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2014-10-01

    Vapotherm Precision Flow Disposable Patient Circuit Recalled for Water Leakage

    Vapotherm, Inc. is recalling 1,005 units of Precision Flow Disposable Patient Circuits because they may allow water to leak into the center gas lumen.

    Product
    Vapotherm Precision Flow,Disposable Patient Circuit PF-E-DPC-High. 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…
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2014-10-01

    Vapotherm Precision Flow Disposable Patient Circuit Recalled for Water Leakage

    Vapotherm, Inc. is recalling 865 units of Precision Flow Disposable Patient Circuits because they may allow water to leak into the center gas lumen.

    Product
    Vapotherm Precision Flow,Disposable Patient Circuit PFHDPC-Low. For use with the Heliox 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…
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2014-10-01

    Vapotherm Precision Flow Disposable Patient Circuit Recalled for Water Leaks

    Vapotherm is recalling 387 Precision Flow Disposable Patient Circuits because they may allow water to leak into the center gas lumen.

    Product
    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…
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2014-10-01

    Vapotherm Precision Flow Disposable Patient Circuit Recall for Water Leakage

    Vapotherm, Inc. is recalling 360 units of Precision Flow Disposable Patient Circuits because they allow water to leak into the center gas lumen.

    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
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2014-10-01

    Vapotherm Precision Flow Disposable Patient Circuit Recalled for Water Leakage

    Vapotherm, Inc. is recalling 635 units of Precision Flow Disposable Patient Circuits because they may allow water to leak into the center gas lumen.

    Product
    Vapotherm Precision Flow,Disposable Patient Circuit PFH-DPC-High. For use with the Heliox 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…
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2014-10-01

    Vapotherm Precision Flow Patient Circuits Recalled for Water Leakage

    Vapotherm, Inc. is recalling 22,828 Precision Flow Disposable Patient Circuits because they may allow water to leak into the gas lumen.

    Product
    Vapotherm Precision Flow, Disposable Patient Circuit PF-DPC-High. 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…
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2014-10-01

    Vapotherm Precision Flow Patient Circuit Recalled for Potential Water Leakage

    Vapotherm, Inc. is recalling 207 units of Precision Flow Disposable Patient Circuits because water may leak into the center gas lumen.

    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…
    Category
    Distribution
    0 states