Ventlab Manual Resuscitator Recall Issued Due to Risk of Death, Injury

More than 14,000 Ventlab manual resuscitators are being recalled, due to the risk of potential leaks, which could put patients’ lives in danger. 

The manual resuscitator recall was announced by the FDA last week, impacting devices manufactured by Ventlab Corporation and sold under a number of different brand names.

Included are the Airflow, Statcheck, SafeSpot, Premium and RescueMed resuscitators sold under the Ventlab label; the Provider Enterprises Adult Resuscitator; as well as the SafeSpot Infant Resuscitators sold under the Provider and BreathTech labels.

The action has been categorized as a Class I medical device recall, indicating that the FDA believes the continued use of the manual resuscitators pose a reasonable probability of causing severe injury or death. However, there are reportedly no injuries or deaths related linked to the devices.

The recalled resuscitators are used to deliver temporary breathing support to adults and children when they are unable to breathe on their own. They are used by emergency medical technicians and health care professionals.

The Ventlab Manual resuscitator units have a valve leak that may prevents the oxygen from getting to the patient. The leak may not be immediately apparent, because the bag still deflates as normal when compressed. The problem was discovered when a defective resuscitator was used by a customer.

The recall affects 14,602 disposable, manual resuscitators, with a complete list of affected lot numbers available in the recall notice. The products can be identified by the part number, description and the lot numbers, which are located on small white labels on the packaging bag. They were manufactured and distributed between March and July 2012.

In June, Ventlab Corporation sent a letter to customers, requesting that they check their inventories for certain resuscitators and return a response form to let the company know if it had them in stock. The company is now in the process of arranging to have the affected units replaced. Customers with questions can call (800) 593-5654 or sent an email to csr@ventlab.com.