Recall Z-1781-2010

Defibtech LLC · initiated May 21, 2010

Terminated

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.

Codes / lots: Serial Numbers range from 202001005 through 202005916 and 206001001 through 206009871.

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: Device Design

Action taken

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.

Details

Recall number
Z-1781-2010
Initiated
May 21, 2010
Posted by FDA
June 10, 2010
Terminated
September 29, 2020
Product code
MKJ – Automated External Defibrillators (Non-Wearable)
Distribution
Worldwide Distribution -- United States, Canada, Australia, Jordan, Spain, Israel, UK, Poland, Italy, Netherlands, Malaysia and Ireland.
Recalling firm
Defibtech LLC, Seymour, CT

Official FDA recall record

Other products in the same recall event

RecallProductInitiated
Z-1782-2010 ReviveR AED semiautomatic external defibrillator used with the DBP-2800 Battery Pack.…The AED when used with an affected battery pack, may falsely detect an error condition, cancel charge and… 05/21/2010Terminated