Some LIFEPAK CR Defibrillators Recalled

Physio-Control, Inc. and the Food and Drug Administration today are announcing the Class I recall of certain LIFEPAK CR Plus Automated External Defibrillators (AEDs), which may malfunction in humid weather and improperly read heart rhythms.

The portable devices are used by emergency medical technicians, other medical personnel, and the general public during the administration of cardio pulmonary resuscitation (CPR). The defibrillator is used to analyze a patient’s heart rhythm and deliver an electrical shock to the heart to restore normal heart rhythm when necessary to avoid cardiac arrest.

In an extremely humid environment, the recalled devices may malfunction, possibly delaying life-saving measures and treatment, the FDA said.

Class I Recall Ordered

Today’s action by the FDA and Redmond, Wa.-based Physio-Control, Inc. is a Class I recall, the most serious call-back action the agency and manufacturers can issue. Such urgent recalls are reserved for situations where the FDA concludes there is a reasonable probability that the use of the products will result in serious injury or death to consumers.

The recalled AEDs were made and distributed by Physio-Control between July 9, 2008 and August 19, 2008.

Only certain serial numbers of defibrillators manufactured and distributed from July 9, 2008 through August 19, 2008 are being recalled. For a complete listing of the serial numbers covered by today’s recall, see the FDA recall notice.

Customers Notified, Replacement Units Sent

Physio-Control called their customers in mid-August 2009 and sent a follow-up email message the next day. The company sent replacements on August 19, 2009, the FDA said.

No related posts.