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Heartstart defibrillation pads

Official notice

21 Mar 2022

Last checked

21 Mar 2022

Medium riskHealth Canada

An official Health Canada notice concerns Heartstart defibrillation pads. HS1/onsite/home AED pads (pn: m5071a, m5072a) have been observed to experience gel separation from the foam/tin backing when peeled from the yellow plastic liner. The gel may fold onto itself resulting in reduced surface area of gel on the pad, or it may separate almost completely leaving only a small amount of gel on the pad. Any pad currently installed in or stored with an HS1/onsite/home aed could experience this problem, and it is not possible to know prior to patient use if your pad is affected because the pads are protected by a foil seal. Recall start date: Mar 2, 2022 Published 2022-03-21.

What to do now

Contact the manufacturer if you require additional information.

Recall number

64007

Official notice

2022-03-21

The hazard

HS1/onsite/home AED pads (pn: m5071a, m5072a) have been observed to experience gel separation from the foam/tin backing when peeled from the yellow plastic liner. The gel may fold onto itself resulting in reduced surface area of gel on the pad, or it may separate almost completely leaving only a small amount of gel on the pad. Any pad currently installed in or stored with an HS1/onsite/home aed could experience this problem, and it is not possible to know prior to patient use if your pad is affected because the pads are protected by a foil seal. Recall start date: Mar 2, 2022

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

64007

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Affected products

Product 1

Affected Products - Heartstart Defibrillation Pads, Lot or Serial Number - Not applicable., Model or catalog number - M5071A, M5072A

Risk / hazard

HS1/onsite/home AED pads (pn: m5071a, m5072a) have been observed to experience gel separation from the foam/tin backing when peeled from the yellow plastic liner. The gel may fold onto itself resulting in reduced surface area of gel on the pad, or it may separate almost completely leaving only a small amount of gel on the pad. Any pad currently installed in or stored with an HS1/onsite/home aed could experience this problem, and it is not possible to know prior to patient use if your pad is affected because the pads are protected by a foil seal. Recall start date: Mar 2, 2022

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: Philips, Heartstart Defibrillation Pads.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

64007

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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