Recall Class: Class I
Date Recall Initiated: May 16, 2014
Product: Ventlab Manual Resuscitator
Trade Names: Airflow Bag, Breath Tech Bag, Provider Bag, STAT-Check Bag, Safe Spot Bag, V-Care Bag, Medline Bag, RescuMed Bag, VT1000 Kit
See Firm Press Release for Resuscitation Bag Series, Features, Lot Numbers, and Manufacturing Dates.
The affected recalled devices were manufactured and distributed from January 10, 2013 through July 1, 2013.
This recall is not expected to cause a device shortage.
Use: The Ventlab Manual Resuscitator is a disposable device used to provide temporary support to patients who cannot breathe on their own. The device should only be used by personnel trained in CPR procedures and is primarily used in hospitals, clinics, and by emergency personnel.
2710 Northridge Drive, NW, Suite Q
Grand Rapids, Michigan 49544-9112
Reason for Recall: The duckbill valve inside the resuscitator may stick and prevent air from getting through the valve and to the patient. If a patient does not receive oxygen or treatment is delayed, life-threatening health consequences including inadequate oxygen supply to the tissues (hypoxia) and too shallow or too slow breathing (hypoventilation) as well as death may occur.
The firm received one report of injury requiring medical intervention due to the lack of a functioning resuscitation bag.
Public Contact: Users with questions may contact Ventlab at 1-844-635-5326, Monday through Friday, 8:30 a.m. - 5:00 p.m., Eastern Time or by email at PFA@ventlab.com.
FDA District: Detroit District Office
More Information about this Recall:
On May 13, 2014, the firm issued a Press Release announcing a recall of affected lots of Ventlab Resuscitator Bags. Users who have the affected resuscitation bags should stop using them and immediately contact Ventlab, LLC. for further instructions on the return of these products.
Ventlab, LLC contacted their distributors and customers by direct mail. The firm is arranging for the return and replacement of all recalled resuscitation bags.
About Class I Recalls
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.