No image published for this recall

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Cardiohelp-i

Official notice

4 Dec 2023

Last checked

4 Dec 2023

Medium riskHealth Canada

An official Health Canada notice concerns Cardiohelp-i. The quality issue under investigation is applicable to the "connection cable venous probe, l0.23m". The part causing the nonconformance under investigation is responsible for data transmission between the Cardiohelp-i and the venous probe. A noticeable high number of breaks in the insulation sheath and a shielding breach of the venous probe connection cable was observed. Recall Start Date: November 21, 2023 Published 2023-12-04.

What to do now

Contact the manufacturer if you require additional information.

Recall number

74679

Official notice

2023-12-04

The hazard

The quality issue under investigation is applicable to the "connection cable venous probe, l0.23m". The part causing the nonconformance under investigation is responsible for data transmission between the Cardiohelp-i and the venous probe. A noticeable high number of breaks in the insulation sheath and a shielding breach of the venous probe connection cable was observed. Recall Start Date: November 21, 2023

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

74679

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Affected products

Product 1

Affected products - Cardiohelp-i, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - 70104.8012

Risk / hazard

The quality issue under investigation is applicable to the "connection cable venous probe, l0.23m". The part causing the nonconformance under investigation is responsible for data transmission between the Cardiohelp-i and the venous probe. A noticeable high number of breaks in the insulation sheath and a shielding breach of the venous probe connection cable was observed. Recall Start Date: November 21, 2023

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: Maquet Cardiopulmonary, Cardiohelp-i.

Source & status

Source

Health Canada

Tier

official

Category

HOME

Classification

Type II

App estimate

medium

Recall details

Recall number

74679

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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