[Posted 05/16/2014]

AUDIENCE: Risk Manager, Emergency Medicine, Anesthesiology

ISSUE: Ventlab, LLC. initiated a voluntary medical device removal of certain Ventlab Resuscitator Bags after becoming aware of complaints regarding a sticking duckbill valve that resulted in the resuscitation bags delivering no air through the patient valve, to the patient. Resuscitation bags affected may not function properly and may result in a delay of treatment and life threatening health consequences that include hypoxia and hypoventilation.

BACKGROUND: Please refer to the firm's press release for a list of recalled models.

RECOMMENDATION: Users who have resuscitation bags within the lot numbers listed in the firm's press release should stop using them and immediately contact Ventlab, LLC. for further instructions on the return of these products.

Ventlab, LLC. will notify its distributors and customers by a direct mailing and arrange for the return and replacement of all of the recalled resuscitation bags. Users with questions may contact Ventlab LLC. via telephone at 1-844-635-5326 between the hours of 8:30 AM to 5:00 PM (EST) Monday through Friday. Consumers may also contact the company via e-mail at PFA@ventlab.com.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[05/14/2014 - Recall Notice - FDA]