HeartSine® Samaritan® PAD SAM 350P/SAM 360P/SAM 500P
Brand(s)
Last updated
Summary
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
Affected 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.
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
Recall date
Identification number
RA-82379
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