Medical Device Recall Advisory

TO:	DDS Regional Directors, STS Director, CTH Coordinators, Private Providers, CO Quality Management Personnel
FROM:	David Carlow, DDS Director of Health Services and Daniel A. Micari, Director, Quality Management Services
DATE:	March 26, 2009
RE:	MEDICAL DEVICE RECALL ADVISORY: AED 10 and MRL JumpStart external defibrillators Class 1 Recall

Medical Device Recall Advisory

The FDA Safety Information and Adverse Event Reporting Program (MedWatch) and Welch Allen notified healthcare professionals and consumers of a nationwide Class I recall of 14,054 AED 10 and MRL JumpStart external defibrillators manufactured between October 3, 2002 and January 25, 2007. These devices may experience low energy shock, unexpected device shutdown, and/or susceptibility to electromagnetic noise interference. If such issues arise, it may prevent defibrillation of a patient in cardiac arrest and could lead to death. Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the product will cause serious injury or death. See the Recall Notice for additional instructions and contact information.

Read the MedWatch safety summary, including a link to the Recall Notice, at:

http://www.fda.gov/medwatch/safety/2009/safety09.htm#AED10

Please ensure those responsible are aware of this medical device recall advisory. Per the direction of the DDS Director of Health Services all agencies (public and private) should forward this information to their nursing staff. Any questions regarding this medication advisory should be directed to David Carlow, DDS Director of Health Services at (860) 418-6083.