Defibtech Defibrillation Pads Mislabeled, Creating Risk of Expired Pads in Use
Defibtech DDP-100 defibrillation pads distributed in Ireland had authorized labels replaced with unauthorized ones, making expired pads appear fresh. Dried hydrogel on expired pads may fail to deliver adequate energy for cardiac resuscitation.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries and a theoretical hazard (expired pads could appear fresh, potentially resulting in poor electrical connection). Per the rubric criterion for 'risk-of-harm products where injury has not yet been reported,' the score is 3 (High).
Plain-English summary
Defibtech, LLC is issuing a Field Safety Notice for select Defibtech DDP-100 Adult Defibrillation Pads distributed in the Irish market. These pads, intended for use with Lifeline and Lifeline Auto AED models for treating sudden cardiac arrest, had their authorized labeling removed and replaced with unauthorized labeling.
The labeling change creates a risk that expired defibrillation pads could appear to have an acceptable shelf life when they do not. Over time, the hydrogel in expired pads may dry out, resulting in poor electrical connection to the patient and reduced energy delivery during treatment.
Approximately 22,294 units were affected by this labeling issue in Ireland. Organizations and facilities should verify the authenticity and expiration dates of their Defibtech DDP-100 pads and discontinue use of any pads with questionable labeling or expired dates. Contact Defibtech, LLC to confirm the status of affected products.
The recalled product
- Product
- Defibtech DDP-100 Adult Defibrillation Pads For use with AED Models: Lifeline and Lifeline Auto (DDU-1:XX Series)- Indicated for use on victims of sudden cardiac arrest (SCA)
- Manufacturer
- Defibtech, LLC
- Affected units
- 22,294
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- UDI-DI: 00815098020423
- DDP-100 adult defibrillation pads
- single configuration
- 30815098020424
- 10 pairs
- 50815098020428
- 40 pairs
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 4 recalled by Defibtech, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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