Safety

Recall -- Firm Press Release

 

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

 

Ventlab, LLC. Issues a Nationwide Recall of Ventlab Resuscitator Bags Due to Possible Health Risk

 

Contact:
Consumer:
(844) 635-5326
Email: PFA@ventlab.com  

FOR IMMEDIATE RELEASE - May 14, 2014 - Ventlab LLC. of Grand Rapids, Michigan has initiated a voluntary medical device removal of a limited number of 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. The valves may stick due to incomplete curing during the manufacturing process. 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.

End users who have resuscitation bags within the lot numbers listed below should stop using them and immediately contact Ventlab, LLC. for further instructions on the return of these products.

The table below provides the resuscitation bag series, features, respective lot numbers and manufacture dates of the recalled models: 

RESUSCITATION BAG SERIESFEATURESLOT NUMBERS MANUFACTURE DATES
AF1000, AF2000, AF5000, BT4000, VN2000, VN5000, VT1000W/ MANOMETER105147 - 10760901/10/2013 - 05/21/2013
AF1000, AF2000, AF3000, AF4000, AF5000, BT2000, BT3000, BT4000, PRO-1900, SC7000, SC8120, SS3200, VN2000, VN3000, VN4000, VN5000W/ MANOMETER AND W/ POP-OFF VALVE106245 - 10729103/04/2013 - 05/06/2013
VN2102W/ MANOMETER AND W/ POP-OFF VALVE2003496/20/2013
AF1000, AF2000, AF3000, AF4000, AF5000, BT2000, BT3000, BT4000, BT5000, BVM700, CPRM2000, CPRM3000, PRO-1000, PRO-2000, SC7000, SC8020, VN2000, VN3000, VN4000W/ MANOMETER AND W/ POP-OFF VALVE107029 - 10763404/11/2013 - 05/23/2013
VN2002W/ MANOMETER AND W/ POP-OFF VALVE2004927/1/2013
SC8000, SC9000W/O MANOMETER AND W/O POP-OFF VALVE101441 - 10746105/17/2012 - 05/09/2013
CPRM1000W/O MANOMETER AND W/O POP-OFF VALVE99523 - 10731502/14/2012 - 05/02/2013


The recalled products were distributed nationwide and can be identified by the part number, description and lot number on the case labels, as well as a small white label on the individual packaging bag.

There has been one report of injury requiring medical intervention due to the lack of a functional resuscitation bag and 31 reports of a delay in oxygenation due to the requirement to utilize a 2nd or 3rd device. The FDA has been notified of this voluntary action by Ventlab, LLC.

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 listed above.

End 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.

Adverse reactions or quality problems experienced with the use of these products may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

###

RSS Feed for FDA Recalls Information [what's this?]

Page Last Updated: 05/16/2014
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.