Recall MonitorHealth Products
HeartSine® Samaritan® Pads
· Published by Health Canada · Official notice
Details
Alert type: Health product recall
Category: Health products - Medical devices - Cardiovascular
Product: HeartSine® Samaritan® Pads
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Industry
Recall class: Type II
Products
| Affected products | Lot or serial number | Model or catalog number |
|---|---|---|
| HeartSine® Samaritan® Pad 360P | More than 10 numbers, contact manufacturer. | 360-BAS-CN-10 360-BAS-CF-10 360-STR-CF-10 360-STR-CN-10 360-TSO-CN-10 |
| HeartSine® Samaritan® Pad 350P | More than 10 numbers, contact manufacturer. | 350-TSO-CN-10 350-BAS-CN-10 350-BAS-CF-10 350-STR-CN-10 |
| HeartSine® Samaritan® Pad 500P | More than 10 numbers, contact manufacturer. | 500-STR-CF-10 500-STR-CN-10 500-BAS-CN-10 500-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