Health product recall

Perfusion Set With Bioline Coating

Last updated

Summary

Product
Perfusion Set With Bioline Coating
Issue
Medical devices - Labelling and packaging
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalogue number

Perfusion Set With Bioline Coating

More than 10 numbers, contact manufacturer.

BEQ-HQV 46904

Issue

It was discovered that, in transitioning from versions 19 to 20 of the technical drawings, the PLEGIOX component was omitted on the drawing which, subsequently, resulted in the omission of the PLEGIOX IFU in the tubing pack.  The affected lot numbers are missing the instructions for use for the PLEGIOX component in the tubing pack.

Recall start date: December 2, 2024

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - General hospital and personal use
Companies
Maquet Cardiopulmonary Gmbh
Kehler Strasse 31, Rastatt, Germany, 76437
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-76653

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