Pediatric defibrillation pads recalled due to labeling and hydrogel degradation
Defibtech DDP-200P pediatric defibrillation pads distributed in Ireland are recalled due to unauthorized labeling that could make expired pads appear current, and hydrogel drying that may reduce electrical effectiveness.
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: FDA Class II medical device used in emergency cardiac care. Although no injuries have been reported, the product presents a clear risk of harm through potential failure to deliver defibrillation energy. This meets the criterion for High severity: risk-of-harm products where injury has not yet been reported.
Plain-English summary
Defibtech, LLC has issued a Field Safety Notice for DDP-200P Pediatric Defibrillation Pads, devices for use with Lifeline and Lifeline Auto AED models in treating sudden cardiac arrest. The recall affects approximately 22,294 units distributed in Ireland.
A labeling issue affects a select number of units: authorized labels were removed and replaced with unauthorized labels. This creates a risk that expired defibrillation pads could appear to be within acceptable shelf life, potentially allowing expired units to remain in use.
Additionally, affected pads may experience hydrogel drying, which can result in poor electrical connection to the patient and reduced energy delivery during defibrillation. No illnesses or injuries related to this issue have been reported.
Facilities and individuals using these pads should verify label authenticity and check expiration dates. Any units suspected of being affected should be removed from service and replaced with correctly labeled products.
The recalled product
- Product
- Defibtech DDP-200P: Pediatric Defibrillation Pads 0 For use with AED Models: Lifeline and Lifeline Auto (DDU-l 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: 00815098020430
- DDP-200P pediatric defibrillation pads
- single pair
- 10815098020437
- single pair configuration
- 40815098020438
- 20 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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