Lifeline recallZ-1312-2023 · Defibtech, LLC · initiated Feb 14, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Defibtech, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 root cause category: Device Design
What the company is doing
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 [email protected] 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 [email protected]. 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 [email protected].
Recall details
- Recall number
- Z-1312-2023
- Status
- Open, Classified
- Initiated by the company
- Feb 14, 2023
- Posted by the FDA
- Mar 30, 2023
- Recalling firm
- Defibtech, LLC
- Quantity
- 29 units
- Product code
- MKJ
- Distribution
- US Nationwide distribution.
Product description
DDU-100 Lifeline Automated External Defibrillator (AED)-Indicated for use on victims of sudden cardiac arrest
Code information (models, lots, serial numbers)
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
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Lifeline DDU-100ADefibtech, L.L.C. · Automated External Defibrillators (Non-Wearable)1 recall3 deaths640 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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