Maquet Hemoconcentrator Set With Softline Coating
Brand(s)
Last updated
Summary
Product
Hemoconcentrator Set With Softline Coating
Issue
Medical devices - Performance
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Affected products
| Affected products | Lot or serial number | Model or catalog number |
|---|---|---|
| Hemoconcentrator Set With Softline Coating | 3000382838 701052273 3000361271 701074294 3000407060 701035333 3000393741 | BO-H 48773 |
Issue
An issue with eight technical drawings, specifically the absence of the bonding symbol for certain connections on the tubing set was found. It is important to note that the specified bonding procedure, which involved the use of cyclohexanone, was not carried out. While the absence of the bonding on the connectors may not be immediately apparent, it could potentially lead to leakage in the affected connections.
Recall start date: December 9. 2024
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Cardiovascular
Companies
Maquet Cardiopulmonary GmbH
Kehler Strasse 31, Rastatt, Germany, 76437
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-76715
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