Permanent Life Support and HLS Sets
Brand(s)
Last updated
Summary
Product
Permanent Life Support and HLS Sets
Issue
Medical devices - Sterility
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 |
|---|---|---|
| Permanent Life Support Set | More than 10 numbers, contact manufacturer. | BE-PLS 2051 BE-PLS 2050 |
| HLS Set Advanced 5.0 With Bioline Coating | More than 10 numbers, contact manufacturer. | 701069068 BEQ-HLS 5050-CA |
| HLS Set Advanced 7.0 With Bioline Coating | More than 10 numbers, contact manufacturer. | 701069065 BEQ-HLS 7050-CA |
Issue
Potentially compromised sterile barrier. The conformity of the products was questioned by the German health authority due to packaging tests not adequately performed. Single sterilized and transport conditioned according to ASTM d4169-22 was conducted. However, the test samples were not double sterilized to cover an assumed worst condition of sterilization impact. These required tests are currently under way, however these test results will not be available until earliest in April 2023.
Recall start date: January 9, 2023
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Cardiovascular
Health products - Medical devices - Gastroenterology and urology
Companies
Maquet Cardiopulmonary Gmbh
Kehler Strasse 31, Rastatt, Germany, 76437
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-72591
Get notified
Receive notifications for new and updated recalls and alerts by category.