Defibtech Pediatric Defibrillation Pads: Mislabeling and Hydrogel Drying Risk
Defibtech DDP-2002 pediatric defibrillation pads distributed in Ireland may be mislabeled with unauthorized labels, potentially making expired pads appear current. Hydrogel drying could impair electrical connection and reduce energy delivery during treatment.
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 of a critical medical device used in emergency cardiac care. No illnesses or injuries have been reported, and the hazards are potential rather than realized. Per the rubric, risk-of-harm products where injury has not yet been reported score as High.
Plain-English summary
Defibtech, LLC is recalling select DDP-2002 pediatric defibrillation pads designed for use with Lifeline View Auto, Lifeline Pro, Lifeline ECG, and Lifeline View (DDU-2XXX Series) automated external defibrillators (AEDs). These pads are indicated for use on victims of sudden cardiac arrest. Approximately 22,294 units were distributed in Ireland.
Some of the recalled pads have had their authorized labels removed and replaced with unauthorized labels. This creates a risk that expired pads may appear to be within acceptable shelf life. Additionally, the pads may experience hydrogel drying, which can result in poor electrical connection to the patient and reduced energy delivery during treatment.
Defibtech has issued a Field Safety Notice regarding this issue. Healthcare facilities and providers in Ireland who received these pads should verify the labeling, check shelf life, and inspect for signs of hydrogel degradation before use. These pads should not be used if they are expired or show signs of hydrogel drying.
The recalled product
- Product
- Defibtech DDP-2002: Pediatric 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
- 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 (8)
- UDI-DI: 00815098020454
- DDP-2002
- pediatric defibrillation pads
- single pair
- 10815098020451
- single pair configuration
- 40815098020452
- 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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