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Heartsine® samaritan® pads

Official notice

18 Jun 2025

MediumHealth Canada

An official Health Canada notice concerns Heartsine® samaritan® pads. 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 Published 2025-06-18.

What to do now

Contact the manufacturer if you require additional information.

Recall number

77621

Official notice

2025-06-18

The hazard

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

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Recall Numbers

77621

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Affected products

Product 1

Affected products - HeartSine® Samaritan® Pad 360P, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - 360-BAS-CN-10

Product 2

Affected products - HeartSine® Samaritan® Pad 360P, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - 360-BAS-CF-10

Product 3

Affected products - HeartSine® Samaritan® Pad 360P, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - 360-STR-CF-10

Product 4

Affected products - HeartSine® Samaritan® Pad 360P, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - 360-STR-CN-10

Product 5

Affected products - HeartSine® Samaritan® Pad 360P, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - 360-TSO-CN-10

Product 6

Affected products - HeartSine® Samaritan® Pad 350P, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - 350-TSO-CN-10

Product 7

Affected products - HeartSine® Samaritan® Pad 350P, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - 350-BAS-CN-10

Product 8

Affected products - HeartSine® Samaritan® Pad 350P, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - 350-BAS-CF-10

Product 9

Affected products - HeartSine® Samaritan® Pad 350P, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - 350-STR-CN-10

Product 10

Affected products - HeartSine® Samaritan® Pad 500P, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - 500-STR-CF-10

Product 11

Affected products - HeartSine® Samaritan® Pad 500P, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - 500-STR-CN-10

Product 12

Affected products - HeartSine® Samaritan® Pad 500P, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - 500-BAS-CN-10

Product 13

Affected products - HeartSine® Samaritan® Pad 500P, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - 500-BAS-CF-10

Risk / hazard

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

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Heartsine, Heartsine® Samaritan® Pads.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

77621

Classification

Type II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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