Health product recall

Cardiohelp-I

Last updated

Summary

Product
Cardiohelp-I
Issue
Medical devices - Manufacturing defect
What to do

Contact the manufacturer if you require additional information.

Affected products

Affected Products

Lot or Serial Number

Model or catalog number

Cardiohelp-I

90414279, 90414282, 90414281, 90414303

70104.8012

Issue

Maquet Cardiopulmonary Gmbh has determined during the testing of a Cardiohelp-I, that the cylindrical pin in the upper part of the transport guard can come loose. the transport guard is an accessory of the Cardiohelp-I and secures the oxygenator to the drive during inter/intra-hospital transportation if no sprinter cart/ sprinter cart xl is used. The detected nonconformity is restricted only to transport guards distributed with specific serial numbers of Cardiohelp-I.

Recall start date: Feb 22, 2022

Additional information

Details
Original published date: 2022-02-28
Alert / recall type
Health product recall
Category
Health product - Medical device - Gastroenterology & Urology
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-63949