HeartSine® Samaritan® Pads
Brand(s)
Last updated
Summary
Product
HeartSine® Samaritan® Pads
Issue
Medical devices - Performance
What to do
Contact the manufacturer if you require additional information.
Audience
Industry
Affected products
| Affected products | Lot or serial number | Model or catalog number |
|---|---|---|
| HeartSine® Samaritan® Pad 360P | More than 10 numbers, contact manufacturer. | 360-BAS-CN-10 |
| HeartSine® Samaritan® Pad 360P | More than 10 numbers, contact manufacturer. | 360-BAS-CF-10 |
| HeartSine® Samaritan® Pad 360P | More than 10 numbers, contact manufacturer. | 360-STR-CF-10 |
| HeartSine® Samaritan® Pad 360P | More than 10 numbers, contact manufacturer. | 360-STR-CN-10 |
| HeartSine® Samaritan® Pad 360P | More than 10 numbers, contact manufacturer. | 360-TSO-CN-10 |
| HeartSine® Samaritan® Pad 350P | More than 10 numbers, contact manufacturer. | 350-TSO-CN-10 |
| HeartSine® Samaritan® Pad 350P | More than 10 numbers, contact manufacturer. | 350-BAS-CN-10 |
| HeartSine® Samaritan® Pad 350P | More than 10 numbers, contact manufacturer. | 350-BAS-CF-10 |
| HeartSine® Samaritan® Pad 350P | More than 10 numbers, contact manufacturer. | 350-STR-CN-10 |
| HeartSine® Samaritan® Pad 500P | More than 10 numbers, contact manufacturer. | 500-STR-CF-10 |
| HeartSine® Samaritan® Pad 500P | More than 10 numbers, contact manufacturer. | 500-STR-CN-10 |
| HeartSine® Samaritan® Pad 500P | More than 10 numbers, contact manufacturer. | 500-BAS-CN-10 |
| HeartSine® Samaritan® Pad 500P | More than 10 numbers, contact manufacturer. | 500-BAS-CF-10 |
Issue
It was determined during rigorous quality testing that a manufacturing process-related issue may impair the device's ability to function or cause failure. The likelihood of this occurring is 0.0128% (low/remote).
Recall start date: May 14, 2025
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Cardiovascular
Companies
Heartsine Technologies, Ltd.
207 Airport Road West, Belfast, Northern Ireland, United Kingdom, BT3 9ED
Published by
Health Canada
Audience
Industry
Recall class
Type II
Identification number
RA-77621
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