Defibtech Announces a Voluntary Recall of DBP-2800 Battery Packs, FDA Determines Action as Class 1
On June 4, 2010, Defibtech, LLC, initiated a voluntary recall of 5,418 DBP-2800 Battery Packs used in the Lifeline AED(R) and ReviveR AED(TM) (semi-automatic external defibrillators). This recall affects all DBP-2800 Battery Packs shipped prior to June 4, 2007. The U.S. Food and Drug Administration has determined that this action is a Class I recall. The affected battery packs are used in AEDs which can be identified by the words "Lifeline AED(R)" and "ReviveR AED(TM)" on the front of the device.
The company has identified recommendations for individuals to follow until the battery pack has been corrected, which allows the battery pack to remain in service. A copy of these recommendations is being mailed to all affected customers.
- View Defibtech's customer notification for instructions on determining whether a battery pack is affected.
The correction to the battery pack will be able to be performed at the location where the battery pack is deployed using any DDU-100 series AED and a Defibtech supplied battery pack update card. The battery pack update is expected to be available within the next two weeks.
Note: Any adverse reactions experienced with the use of this product and/or quality problems should also be reported to the FDA's MedWatch Program by phone at 1-800-FDA-1088, or on the MedWatch website at www.fda.gov/medwatch.
Visit Defibtech's website for additional information regarding this recall, or contact Defibtech at techsupport@defibtech.com, 1-877-453-4507 or 1-203-453-4507.
