Heartsine AED Electrode Pouches Recalled for Difficulty Opening
Heartsine is recalling Pad-Pak and Pedi-Pak electrode accessories for the Samaritan PAD 300P and 350P because some sealed foil pouches are difficult to open, potentially delaying therapy.
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: The recall is classified as FDA Class II and involves a risk-of-harm product (AED electrodes) where the defect could delay life-saving therapy, but no injuries or illnesses have been reported.
Plain-English summary
Heartsine Technologies, Limited is recalling Pad-Pak and Pedi-Pak accessories for the HeartSine Samaritan PAD 300P and 350P devices. These products are automated external defibrillator (AED) electrode supplies. The recall involves 3,245 units distributed nationwide in the US, as well as in Canada, Mexico, and Latin America. The affected products include Pad-Pak 01 and Pad-Pak 02 with adult lot numbers A1785 to A1805 and pediatric lot numbers P433 to P445.
The recall was initiated because a small number of sealed foil pouches containing the electrodes were found to be difficult to open. This defect could result in a potential delay in therapy during an emergency. The agency has classified this as a Class II recall.
Consumers should check their inventory for the specific lot numbers listed above. If the product is affected, they should stop using it and contact Heartsine Technologies, Limited for instructions on how to return the product or obtain a replacement.
The recalled product
- Product
- Pad-Pak and Pedi-Pak accessories for the HeartSine Samaritan PAD 300P and 350P device (SAM 300P and 350P). Automated External Defibrillator electrode supplies. The Pedi-Pak is specifically designed for use with the HeartSine Samaritan PAD 300P and 350P device. It contains…
- Manufacturer
- Heartsine Technologies, Limited
- Category
- Medical Device — AED Accessories
- Affected units
- 3,245
Distribution
Distributed nationwide across the United States.
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