Respiratory devices company Ventlab Corp. announced a nationwide recall of thousands of its manual resuscitators over concerns that the devices may not delivery enough or any air or oxygen to patients
The recall, which the company initially launched in July, affects more than 14,600 units across 12 different products, including the company’s RescueMed Infant Resuscitator and Premium Small Child Resuscitator, according to a press release.
No patient injuries have been reported to date, the company noted, but the defect "could result in life threatening health consequences that include hypoxia and hypoventilation."
"Ventlab Corporation 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," according to a company statement. "Ventlab Corporation has notified the FDA of this action."
The problem was traced back to assembly issues at the company’s single manufacturing facility, Ventlab spokesman James Cochie told MassDevice.com today, and the company will continue distributed unaffected lots of the manual respirators.
The Mocksville, N.C. company advised that its customers stop using the recalled lots immediately and to contact Ventlab for fuhrer instructions. The affected lots were distributed nationwide between March and July of this year, according to a press release.