Events

Recall of NITRIC OXIDE READY DISPOSABLE PATIENT CIRCUIT LOW

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by TRUDELL MEDICAL MARKETING LIMITED.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    54500
  • Event Risk Class
    II
  • Event Initiated Date
    2014-08-21
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    Vapotherm has received a small number of complaints involving a defect in the disposable patient circuit that allows water to leak into the center gas lumen that is beyond what would be attributed to normal condensation. recall has been issued to raise awareness of this issue and to remind users to follow the instructions for use recommendation that the cannula be connected to the patient only after the set temperature is reached.

Device

NITRIC OXIDE READY DISPOSABLE PATIENT CIRCUIT LOW
  • Model / Serial
    Model Catalog: PF-NODPC-LOW (Lot serial: LFN1404008); Model Catalog: PF-NODPC-LOW (Lot serial: LFN1405011); Model Catalog: PF-E-DPC-LOW (Lot serial: LFE1403002); Model Catalog: PF-DPC-HIGH (Lot serial: >100 numbers contact mfg); Model Catalog: PF-DPC-LOW (Lot serial: >100 numbers contact mfg)
  • Product Description
    NITRIC OXIDE READY DISPOSABLE PATIENT CIRCUIT LOW
  • Manufacturer
    TRUDELL MEDICAL MARKETING LIMITED

Manufacturer

TRUDELL MEDICAL MARKETING LIMITED