PERFUSION SET WITH SOFTLINE COATING (2021-07-27)

Starting date:

July 27, 2021

Posting date:

August 6, 2021

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-76173

Last updated:
2021-08-06

• 
  Reason
• 
  Affected products

Affected Products 

PERFUSION SET WITH SOFTLINE COATING

Reason

The affected tubing sets have a third party arterial filter as a component. During a review of the technical documentation of all tubing sets, the Notified Body of Maquet Cardiopulmonary GmbH has identified the lack in the system testing of the tubing sets with an integrated third party arterial filter. It is not ensured that performance of all required parameters (flow rate, pressure and temperature) within tubing sets are given.Taking into consideration that the third party arterial filters were not tested as a system, Maquet Cardiopulmonary GmbH is unable to confirm that the filter will always function as intended.

Affected products