Recall MonitorHealth Products
HeartSine® Samaritan® PAD SAM 350P/SAM 360P/SAM 500P
· Published by Health Canada · Official notice
Details
Alert type: Health product recall
Category: Health products - Medical devices - Cardiovascular
Product: HeartSine® Samaritan® PAD SAM 350P/SAM 360P/SAM 500P
Issue: Medical devices - Labelling and packaging
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 catalogue 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-TSO-CN-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 |
| 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 |
Issue
Stryker has identified a limited number of HeartSine samaritan PAD devices that were distributed without the required maintenance supplement. This supplement contains periodic maintenance instructions implemented as an additional risk-control measure. While most devices contain the maintenance supplement, this voluntary correction is being initiated to ensure all end users have access to supplemental maintenance information. This issue was identified through a customer complaint.