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Huge Recall of Manual Resuscitators by Ventlab Corp

October 19, 2012 04:29pm  
Huge Recall of Manual Resuscitators by Ventlab Corp

On October 16, 2012, the Food and Drug Administration announced that Ventlab Corporation issued a recall across the nation for a total of 14,602 manual resuscitators.  Ventlab has recalled different models of the resuscitators because the device was found to deliver little or no oxygen to the patient through the valve.

The recalled products put patients in direct danger of hypoxia and hypoventilation.  

Hospitals, clinics, and EMS units need to stop using the manual resuscitators immediately if they were recalled by Ventlab Corporation.  The recalled manual resuscitators were manufactured and distributed between March of 2012 and July of 2012.  

11 different models of the Ventlab AirFlow adult resuscitators were recalled.  Numerous models of the following resuscitators were also recalled:  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 RescueMed infant resuscitator, BreathTech SafeSpot infant resuscitator, Provider Enterprises SafeSpot infant resuscitator, and Provider Enterprises adult resuscitator.  

You can visit the EPA’s website to find the part numbers, lot number, and case labels involved in the recall.  These numbers are located on a small white label on the product’s packaging bag.  

Ventlab Corporation voluntarily recalled the resuscitators after receiving reports that little to no air was passing through the valve.  Ventlab immediately notified the FDA, and no reports of injuries or complications have been reported in connection with the resuscitators.  

Distributers were notified by Ventlab through email or by direct mail.  The mail contains instructions on returning and replacing the products.  

If you have additional questions about the recalled products, you can contact Ventlab Corporation at 1-800-593-5654 between the hours of 8:30 a.m. and 5:00 p.m. on Monday through Friday.  

Source: U.S. Food and Drug Administration


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