Ventlab Recalls Over 14,000 Manual Resuscitators
Ventlab Corp. announced a nationwide medical product recall of 14,602 of its manual resuscitators for a defect that could lead to the threat of hypoxia (low brain oxygen) and hypoventilation (respiratory depression) in patients, which could prove fatal.
Manual resuscitators are designed to provide effective breathing assistance, but a certain batch of Ventlab’s resuscitators was found to be defective as the devices provided little or no oxygen through the breathing valve to the patient, according to the Food and Drug Administration (FDA).
A product incident complaint prompted the company to initiate the recall.
The recalled products — marketed to clinics, hospitals, and EMS units from March 2012 to July 2012 —can be identified by the part number, description, and lot number on case labels, and a white label on the individual packaging bag.
No injuries have been reported so far. The FDA has asked end users to immediately stop using the products from the affected lot and contact Ventlab for instructions on return and replacement.