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U.S. Department of Health and Human Services

Medical Devices

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Ventlab Corporation Adult and Pediatric Manual Resuscitators

Recall Class: Class I

Date Recall Initiated: July 11, 2012

Product: Ventlab Corporation adult and pediatric disposable, manual resuscitators

Model Numbers: Affected model, lot and serial numbers are available on the FDA's website

Manufacturing and Distribution Dates: The affected manual resuscitators were manufactured and distributed between March 2012 and July 2012.

Intended Use: The affected manual resuscitators are disposable devices used to provide temporary breathing support to adult and pediatric patients who cannot breathe on their own.

These devices are often used in health care facilities and by emergency medical services during patient transport or as a backup to ventilators and anesthesia machines.

Recalling Firm:
Ventlab Corporation
155 Boyce Drive
Mocksville, North Carolina 27028-4187

Reason for Recall: The affected manual resuscitators may have a valve leak which prevents the flow of air/oxygen to the patient. This lack of airflow to the patient may not be easily observable to the user because the bag still deflates when compressed. Lack of air/oxygen can cause life-threatening health consequences for patients, including hypoxia, hypoventilation or death.

Public Contact: Consumers with questions may contact Ventlab Corporation at 1-800-593-5654, between the hours of 8:30 AM and 5:00 PM (EST), Monday through Friday. Consumers may also contact the company by e-mail at csr@ventlab.com.

FDA District: Atlanta

FDA Comments: Ventlab Corporation is in the process of arranging for the return and replacement or repair of the manual resuscitators affected by this recall.

The company originally notified customers of this recall in a letter sent June 10, 2012. In the letter, customers were requested to check their facility’s inventory for the affected products and complete and return a response form, included with the letter, to indicate whether or not their facility had any of the affected products.

Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.

Additional Information: