Extracorporeal Tubing Set for Heart-Lung Machine - Perfusion Pack and Art.Cannula - Wire Reinforced, Straight Tip W/Ring, Pre-Mounted Connector (2018-05-07)

Starting date:

May 7, 2018

Posting date:

June 1, 2018

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-66946

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  Reason
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  Affected products

Affected products

A. Extracorporeal Tubing Set for Heart-Lung Machine - Perfusion Pack

B. Art Cannula -  Wire Reinforced, Straight Tip W/Ring, Pre-Mounted Connector

Reason

An arterial cannula used for open heart surgery is normally equipped with a vent plug, which facilitates the de-airing of the cannula. The vent plug of our arterial cannula consists of sintered polyethylene, therefore the structure of the vent plug is porous and gas-permeable. After the de-airing process is completed the customer has to separate the vent plug from the cannula to connect the extracorporeal circuit. In some rare cases it has come the vent plug broke during the separation from the arterial cannula.

Affected products