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Omnipod dash system

Official notice

27 Oct 2022

HighHealth Canada

An official Health Canada notice concerns Omnipod dash system. Through post market surveillance and investigation of returned complaint devices, Insulet has been made aware of pdm battery issues, including battery swelling, fluid leaking from the battery, and in rare cases, extreme overheating, which may pose a fire hazard (thermal runaway events). The health hazard evaluation (HHE) was completed on October 10, 2022 with an analysis of possible causes and hazardous situations with the information that was known at the time. Recall start date: October 17, 2022 Published 2022-10-27.

What to do now

Contact the manufacturer if you require additional information.

Recall number

72079

Official notice

2022-10-27

The hazard

Through post market surveillance and investigation of returned complaint devices, Insulet has been made aware of pdm battery issues, including battery swelling, fluid leaking from the battery, and in rare cases, extreme overheating, which may pose a fire hazard (thermal runaway events). The health hazard evaluation (HHE) was completed on October 10, 2022 with an analysis of possible causes and hazardous situations with the information that was known at the time. Recall start date: October 17, 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

72079

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Affected products

Product 1

Affected products - Omnipod Dash, Pdm, Personal Diabetes Manager, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - PDM-CAN-D001-MM

Product 2

Affected products - Omnipod Dash, Personal Diabetes Manager Kit, Lot or serial number - 139723, Model or catalog number - SKT-CAN-D001-MM

Risk / hazard

Through post market surveillance and investigation of returned complaint devices, Insulet has been made aware of pdm battery issues, including battery swelling, fluid leaking from the battery, and in rare cases, extreme overheating, which may pose a fire hazard (thermal runaway events). The health hazard evaluation (HHE) was completed on October 10, 2022 with an analysis of possible causes and hazardous situations with the information that was known at the time. Recall start date: October 17, 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: Insulet, Omnipod Dash System.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

high

Recall details

Recall number

72079

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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