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U.S. Department of Health and Human Services

Class 1 Device Recall Lifeline AED DDU100 semiautomatic external defibrillator used with the DBP2800 Battery Pack

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  Class 1 Device Recall Lifeline AED DDU100 semiautomatic external defibrillator used with the DBP2800 Battery Pack see related information
Date Initiated by Firm May 21, 2010
Date Posted June 10, 2010
Recall Status1 Terminated 3 on September 29, 2020
Recall Number Z-1781-2010
Recall Event ID 55497
510(K)Number K013896  
Product Classification Automated external defibrillators (non-wearable) - Product Code MKJ
Product Lifeline AED DDU-100 semiautomatic external defibrillator used with the DBP-2800 Battery Pack, Manufactured by Defibtech, LLC. Seymour, CT 06483.

The DBP-2800 battery pack is an accessory to the AED and does not have its own intended use. The AED is intended for use on victims of sudden cardiac arrest when the patient is unconscious, unresponsive and not breathing.
Code Information Serial Numbers range from 202001005 through 202005916 and 206001001 through 206009871.
Recalling Firm/
Manufacturer		 Defibtech LLC
4 Progress Ave
Seymour CT 06483-3921
For Additional Information Contact Al Raebuck
203-453-6654 Ext. 122
Manufacturer Reason
for Recall		 The AED when used with an affected battery pack, may falsely detect an error condition, cancel charge and not provide therapy
FDA Determined
Cause 2		 Device Design
Action Defibtech, LLC issued an "Urgent Medical Device Safety Information and Correction" notification dated May 20, 2010 by email and hard copy via US Mail. The notification instructed Consignees on proper identification of affected product and steps to take for product replacement. For further information, contact your distributor or Defibtech Technical Support at techsupport@defibtech.com or call 1-877-453-4507 or 1-203-453-4507, 8:30 AM to 5:00 PM Monday - Friday, EST.
Distribution Worldwide Distribution -- United States, Canada, Australia, Jordan, Spain, Israel, UK, Poland, Italy, Netherlands, Malaysia and Ireland.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MKJ and Original Applicant = DEFIBTECH, LLC
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