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Maquet hemoconcentrator set with softline coating

Official notice

18 Dec 2024

Last checked

18 Dec 2024

Critical riskHealth Canada

An official Health Canada notice concerns Maquet hemoconcentrator set with softline coating. An issue with eight technical drawings, specifically the absence of the bonding symbol for certain connections on the tubing set was found. It is important to note that the specified bonding procedure, which involved the use of cyclohexanone, was not carried out. While the absence of the bonding on the connectors may not be immediately apparent, it could potentially lead to leakage in the affected connections. Recall start date: December 9. 2024 Published 2024-12-18.

What to do now

Contact the manufacturer if you require additional information.

Recall number

76715

Official notice

2024-12-18

The hazard

An issue with eight technical drawings, specifically the absence of the bonding symbol for certain connections on the tubing set was found. It is important to note that the specified bonding procedure, which involved the use of cyclohexanone, was not carried out. While the absence of the bonding on the connectors may not be immediately apparent, it could potentially lead to leakage in the affected connections. Recall start date: December 9. 2024

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

76715

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Affected products

Product 1

Affected products - Hemoconcentrator Set With Softline Coating, Lot or serial number - 3000382838 701052273 3000361271 701074294 3000407060 701035333 3000393741, Model or catalog number - BO-H 48773

Risk / hazard

An issue with eight technical drawings, specifically the absence of the bonding symbol for certain connections on the tubing set was found. It is important to note that the specified bonding procedure, which involved the use of cyclohexanone, was not carried out. While the absence of the bonding on the connectors may not be immediately apparent, it could potentially lead to leakage in the affected connections. Recall start date: December 9. 2024

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, Hemoconcentrator Set With Softline Coating.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

critical

Recall details

Recall number

76715

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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