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Maquet cardiopulmonary gmbh perfusion sets

Official notice

28 Nov 2023

Last checked

28 Nov 2023

Medium riskHealth Canada

An official Health Canada notice concerns Maquet cardiopulmonary gmbh perfusion sets. Maquet Cardiopulmonary Gmbh received customer complaints for custom tubing packs (CTP) reporting the perforation of the Tyvek, the upper part of the sterile barrier of the packaging. Upon further investigation, the internal components set were found to be untethered/loose with the sterile tray. Recall start date: November 17, 2023 Published 2023-11-28.

What to do now

Contact the manufacturer if you require additional information.

Recall number

74663

Official notice

2023-11-28

The hazard

Maquet Cardiopulmonary Gmbh received customer complaints for custom tubing packs (CTP) reporting the perforation of the Tyvek, the upper part of the sterile barrier of the packaging. Upon further investigation, the internal components set were found to be untethered/loose with the sterile tray. Recall start date: November 17, 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

74663

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Affected products

Product 1

Affected products - Heart Lung Perfusion Pack With Softline, Lot or serial number - 3000212936, Model or catalogue number - BO-HQV 48707

Risk / hazard

Maquet Cardiopulmonary Gmbh received customer complaints for custom tubing packs (CTP) reporting the perforation of the Tyvek, the upper part of the sterile barrier of the packaging. Upon further investigation, the internal components set were found to be untethered/loose with the sterile tray. Recall start date: November 17, 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, Maquet Cardiopulmonary Perfusion Sets.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

74663

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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