Defibtech Adult Defibrillation Pads Recalled for Labeling Error Risk
Defibtech is recalling 22,294 DDP-2001 Adult Defibrillation Pads distributed in Ireland. Some pads had unauthorized labels applied, which could allow expired pads to appear current, and dried hydrogel may reduce electrical delivery during use.
What this means for you
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 of a risk-of-harm medical device (defibrillator) where potential failure could result from expired pads or hydrogel degradation. No illnesses or injuries have been reported, and the hazard is potential rather than manifested.
Plain-English summary
Defibtech, LLC is recalling DDP-2001 Adult Defibrillation Pads. These pads are for use with Lifeline View Auto, Lifeline Pro, Lifeline ECG, and Lifeline View (DDU-2XXX Series) automated external defibrillators. The recall affects 22,294 units distributed in Ireland.
A select number of these pads had their authorized labels removed and unauthorized labels applied. This tampering could allow expired pads to appear as though they are within their acceptable shelf life. Additionally, hydrogel in the affected pads may dry out, resulting in poor electrical connection to the patient and potentially reducing the energy delivered during defibrillation.
Consumers who have received these pads should verify that the labeling is authentic and that the shelf life is valid. If you are uncertain about any pads you have received, contact your supplier or Defibtech, LLC for verification before use.
The recalled product
- Product
- Defibtech DDP-2001: Adult Defibrillation Pads For use with AED Models: Lifeline View Auto, lifeline Pro, lifeline ECG, lifeline View (DDU-2XXX Series). -Indicated for use on victims of sudden cardiac arrest (SCA.)
- Manufacturer
- Defibtech, LLC
- Hazard
- label-tampering
- hydrogel-degradation
- device-failure-risk
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: 00815098020447
- DDP-2001 adult defibrillation pads
- single pack
- 30815098020448
- 10 pairs
- 50815098020442
- 40 pairs
Distribution
Distribution scope not specified by the agency.
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