Ventlab Corporation has issued a nationwide recall of 14,602 manual resuscitators. The manual resuscitators 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. End users who have manual resuscitators that are in the recall should stop using them and immediately contact Ventlab Corporation for further instructions on the return of these products.
Recalled manual resuscitators were manufactured and distributed nationwide to distributers that sold and distributed products to hospitals, clinics and EMS units from March 2012 to July 2012. Products can be identified by the part number, description and lot number on case labels, as well as a small white label on the individual packaging bag. Ventlab Corporation 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. Ventlab Corporation notified the FDA of this action. Thus far no injuries have been reported.
Ventlab Corporation notified its distributors and customers by e-mail notification followed by a direct mailing and is arranging for the return/replacement/rework of all recalled manual resuscitators in the recall. End users with questions may contact the company via telephone at 1-800-593-5654 between the hours of 8:30 AM to 5:00 PM (EST) Monday through Friday. Consumer may also contact the company via e-mail at email@example.com.
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