DDU-100 Lifeline Automated External Defibrillator recall
DDU-100 Lifeline Automated External Defibrillator (AED)-Indicated for use on victims of sudden cardiac arrest
Why was DDU-100 Lifeline Automated External Defibrillator 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- DDU-100 Lifeline Automated External Defibrillator (AED)-Indicated for use on victims of sudden cardiac arrest
- Recalling firm
- Defibtech, LLC
- Quantity
- 29 units
- Distribution
- US Nationwide distribution.
- Recall date
- April 5, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)