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U.S. Department of Health and Human Services

Class 2 Device Recall LifeLine

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  Class 2 Device Recall LifeLine see related information
Date Initiated by Firm February 14, 2023
Date Posted March 30, 2023
Recall Status1 Open3, Classified
Recall Number Z-1312-2023
Recall Event ID 91799
Product Classification Automated external defibrillators (non-wearable) - Product Code MKJ
Product DDU-100 Lifeline Automated External Defibrillator (AED)-Indicated for use on victims of sudden cardiac arrest
Code Information UDI-DI: 00815098020003 Serial Numbers: 101702198 101702263 101702424 101702524 101702535 101702540 101702544 101702545 101703267 101703269 101703272 101703274 101703276 101703277 101703278 101703281 101703312 101703326 101703378 101703407 101703411 101703412 101703419 101703424 101703427 101703464 101703465 101703600 101704106
Recalling Firm/
Manufacturer		 Defibtech, LLC
741 Boston Post Rd
Suite 201
Guilford CT 06437-2714
For Additional Information Contact Defibtech Customer Service
203-453-6654
Manufacturer Reason
for Recall		 A component of a sub-assembly used in the affected AEDs had not undergone durability and reliability testing, and if a malfunction occurs, therefore the device could fail to deliver therapy.
FDA Determined
Cause 2		 Device Design
Action Defibtech issued Urgent Medical Device Safety Removal User letter (FA2023-01) on 2/14/23 and 2/17/23 via email to Distributors and End-Users. Letter states reason for recall, health risk and action to take: 1. Confirm receipt of this notice by checking the Read receipt option in the email notification containing this communication. Additionally, complete, sign and return to FA2023@defibtech.com the attached Receipt Letter acknowledging that you have received this recall notification 2. Check the box label s 9-digit serial number of any units in your inventory against the serial numbers listed in the attachment 3. It is requested you quarantine the listed AEDs and Defibtech will contact you to arrange their return to Defibtech for screening 4. If you have further transferred the device to another entity or department, you must provide this notice to affected parties Please return any affected units as identified in the Attachment for replacement. Dedicated support for handling all aspects of the return of identified units will be provided by Defibtech. We will be contacting you shortly to help you with the process and answer any questions. If you have questions now, please feel free to contact us using the email address FA2023@defibtech.com. Defibtech Customer Support is available by calling 1-877-453-4507, 8:30 A.M. to 5:30 P.M. (Eastern), Monday - Friday. To assure that you have received notification of this safety issue and understand your obligation in notifying those in possession of the serial number(s) shipped to you or on your behalf of any required action, please sign and return this letter to A2023@defibtech.com.
Quantity in Commerce 29 units
Distribution US Nationwide distribution.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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