Health product recall

Custom Tubing Packs

Last updated

Summary

Product
Custom Tubing Packs
Issue
Medical devices - Labelling and packaging
What to do

Contact the manufacturer if you need additional information.

Affected products

Affected Products

Lot or serial number

Model or catalog number

CUSTOM PACK WITH SOFTLINE

92285211
92287249
92287967
92291766

BO-HQV 59203
BO-HQV 59205
BO-HQV 59206

PERFUSION SET WITH SOFTLINE COATING

92276990
92277050
92277198
92279893
92288233

BO-H 55815
BO-H 55816

PERFUSION TUBING PACK WITH BIOLINE COATING

More than 10 numbers, contact manufacturer.

BEQ-H 48715
BEQ-H 48730
BEQ-H 84702

PERFUSION SET WITH BIOLINE COATING

More than 10 numbers, contact manufacturer.

Not Available

Issue

The tubing sets are designed and labeled for 2 years shelf-life from the manufacturing date. However, during a review of the technical documentation of tubing sets, it was found out that there is not sufficient evidence to demonstrate the 2 year shelf life of three 3rd party components integrated into the tubing sets.

 

Recall start date: 2021-11-05

What you should do

Contact the manufacturer if you need additional information.

Additional information

Details
Original published date: 2021-11-18
Alert / recall type
Health product recall
Category
Health product - Medical device - Cardiovascular
Companies

MAQUET CARDIOPULMONARY GMBH

KEHLER STRASSE 31, RASTATT

GERMANY 76437

 

Published by
Health Canada
Audience
General public
Health professionals
Hospitals
Recall class
Type II
Identification number
RA-63600