Events

Recall of Vapotherm" Respiratory Gas Humidifier, Model 2000i, labeled in part ***Vapotherm Inc., Annapolis, MD 21401***.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Vapotherm, Inc..

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
    33935
  • Event Risk Class
    Class 1
  • Event Number
    Z-0360-06
  • Event Initiated Date
    2005-10-13
  • Event Date Posted
    2006-01-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-08-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=42761
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Humidifier, Respiratory Gas, (Direct Patient Interface) - Product Code BTT
  • Reason
    A medical device firm changed the labeling of its respiratory gas humidifier by revising the protocol for higher level disinfectants to be used by healthcare practitioners.
  • Action
    Vapotherm, Inc. reportedly notified distributors and institutional end users via subscriber list-serve with newsletters sent on 10/13/05, 10/31/05 and 11/04/05. The notifications addressed the CDC epidemiological study, in which no definitive information on the source of the organism was identified. The notice states that the firm continued to recommend disinfection between patients and adherence to FDA limitations on the re-use of single patient consumables. Subsequently, Vapotherm reported that they had developed an enhanced disinfecting protocol including a recommendation for using higher level disinfectants and the use of sterile water in the system. The notification refers consignees to the company website for infection prevention and control resources updates. On 12/20/05, Vapotherm notified their list-serve subscribers that they were recalling 2000i devices to conduct a high level disinfectant protocol with the devices to be returned to end users with newly revised labeling to include recommendation for sterile water use and device components designed to provide humidification within a closed system. On 12/22/05, Vapotherm notified distributors and healthcare practitioners via certified mail flagged 'Urgent'. The firm's notification was reportedly sent to hospital respiratory and infection control departments and advised that other therapies, such as nasal CPAP and standard oxygen therapies should be considered during the recall. The notification directs users to the firm's website where users may log on and obtain return authorization for shipping back to the recalling firm. A response form is included with the notification and users are requested to fax back for confirmation of notification.

Device

Vapotherm" Respiratory Gas Humidifier, Model 2000i, labeled in part ***Vapotherm Inc., Annapolis,...
  • Model / Serial
    All S/Ns of the Vapotherm" Model 2000i are affected.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Products were sold to medical device distributors and end users nationwide and in international markets.
  • Product Description
    Vapotherm" Respiratory Gas Humidifier, Model 2000i, labeled in part ***Vapotherm Inc., Annapolis, MD 21401***.
  • Manufacturer
    Vapotherm, Inc.

Manufacturer

Vapotherm, Inc.
  • Manufacturer Address
    Vapotherm, Inc., 198 Log Canoe Circle, Stevensville MD 21666-2128
  • Source
    USFDA