HLS Set Advanced 5.0/7.0 with BIOLINE Coating (2020-11-10)

Starting date:

November 10, 2020

Posting date:

November 20, 2020

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-74359

Last updated:
2020-11-19

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  Reason
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  Affected products

Affected Products

HLS Set Advanced 5.0/7.0 with BIOLINE Coating

Reason

During verification testing and a review of customer complaints for the HLS Set Maquet Cardiopulmonary (MCP) identified a potential impairment of the sterile packaging barrier. Under the transport simulation verification tests, movements of the device and its accessories inside the plastic tray have been identified. As a result the sterile barrier for the system may be compromised.

Affected products