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:

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

HLS Set Advanced 5.0/7.0 with BIOLINE Coating

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

BEQ-HLS 5050-CA
BEQ-HLS 7050-CA

Companies
Manufacturer
Maquet Cardiopulmonary GmbH
Kehler Str. 31
Rastatt
76437
GERMANY