CareFusion (CFN) Updats on AirLife Recall; Says Half of Affect Customers Complete Remediation
Tweet Send to a FriendGet Alerts CFN Hot Sheet
Up)
Trade CFN Now!
CareFusion (NYSE: CFN) issued the following update regarding its voluntary recall of its AirLife™ Infant Breathing Circuit. The FDA has classified this action as a Class 1 recall.
The company initiated the voluntary recall on May 29. The products subject to the recall were manufactured between June 1, 2010, and Feb. 3, 2012. This action has no effect on the manufacture or distribution of current products.
In May 2012, the company sent an urgent Recall Notification to customers and distributors stating the identified potential risks associated with the AirLife Infant Breathing Circuit. The Y-adapter in affected products could develop cracks during patient use, potentially resulting in a leak in the closed ventilation system and leading to a loss in the intended tidal volume delivered to the patient. A Class I recall is defined as a reasonable probability of serious adverse health consequences or death associated with use of the defective units. To date, there have been no reports of patient harm associated with the affected products.
There is no change to the remediation plans previously announced by the company. In the notification letter, customers were provided lot numbers of affected product codes and asked to destroy any affected products remaining in inventory.
Since the recall was initiated in May, nearly half of the affected customers and distributors have completed the remediation process.
Join StreetInsider.com FREE and get immediately alerted when news breaks on your stocks and other market items - JOIN NOW
*NEW - Download StreetInsider's FREE iPhone and iPad App - Click Here
The company initiated the voluntary recall on May 29. The products subject to the recall were manufactured between June 1, 2010, and Feb. 3, 2012. This action has no effect on the manufacture or distribution of current products.
In May 2012, the company sent an urgent Recall Notification to customers and distributors stating the identified potential risks associated with the AirLife Infant Breathing Circuit. The Y-adapter in affected products could develop cracks during patient use, potentially resulting in a leak in the closed ventilation system and leading to a loss in the intended tidal volume delivered to the patient. A Class I recall is defined as a reasonable probability of serious adverse health consequences or death associated with use of the defective units. To date, there have been no reports of patient harm associated with the affected products.
There is no change to the remediation plans previously announced by the company. In the notification letter, customers were provided lot numbers of affected product codes and asked to destroy any affected products remaining in inventory.
Since the recall was initiated in May, nearly half of the affected customers and distributors have completed the remediation process.
Join StreetInsider.com FREE and get immediately alerted when news breaks on your stocks and other market items - JOIN NOW
*NEW - Download StreetInsider's FREE iPhone and iPad App - Click Here
You May Also Be Interested In
- Sanofi (SNY) Reports JAKARTA Met Primary Endpoint in Both Groups
- Santarus (SNTS) to Present Additional Data on UCERIS
- Sciclone (SCLN) Enters Licensing Agreement with Neucardin in East Asia
Create E-mail Alert Related Categories
Corporate News, FDA
Login with Facebook
Sign up for StreetInsider Free!
Receive full access to all new and archived articles, unlimited portfolio tracking, e-mail alerts, custom newswires and RSS feeds - and more!
