Events

Safety Alert for Ventlab manual resuscitators

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Ventlab Corporation.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2012-10-24
  • Event Date Posted
    2012-10-24
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20121024.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: ventlab manual resuscitators the united states food and drug administration (fda) has posted a firm press release concerning ventlab manual resuscitators distributed between march 2012 and july 2012. ventlab corporation, the device manufacturer, initiated a nationwide recall of 14,602 of its manual resuscitators. the manual resuscitators, as listed below have been found to potentially deliver little to no air/oxygen through the patient valve to the patient, which could result in life threatening health consequences that include hypoxia and hypoventilation. the recall includes the following product models: ventlab airflow adult resuscitator ventlab airflow infant resuscitator ventlab airflow small adult resuscitator ventlab statcheck adult resuscitator ventlab safespot infant resuscitator ventlab premium infant resuscitator ventlab premium small child resuscitator ventlab premium small adult resuscitator ventlab rescuemed infant resuscitator breathtech safespot infant resuscitator provider enterprises safespot infant resuscitator provider enterprises adult resuscitator the manufacturer voluntarily recalled the above listed products after becoming aware of a product incident where the nature of the complaint was that the resuscitators were delivering little or no air through the patient valve to the patient. no injuries have been reported to-date. end users who have these manual resuscitators should stop using them and immediately contact ventlab corporation or your supplier for further instructions on the return of these products. for details, please refer to the following fda website http://www.Fda.Gov/safety/recalls/ucm324561.Htm if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 24 october 2012.

Device

Ventlab manual resuscitators
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Ventlab manual resuscitators
  • Manufacturer
    Ventlab Corporation

Manufacturer

Ventlab Corporation