Health product recall

Heater-Cooler Unit 30 System (2020-02-05)

Starting date:
February 5, 2020
Posting date:
February 21, 2020
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-72375

Last updated: 2020-02-21

Affected Products

Heater-Cooler Unit 30 System

Reason

Revised instructions for use - water quality management heater-cooler unit HCU 30 (MCV-GK-10000706). These new procedures will maintain the water circuits of HCU 30 clean and plumbing and provide reproducible and constant system water conditions, which create a "microbial unfriendly" environment - also against atypical mycobacteria.

Affected products

Heater-Cooler Unit 30 System

Lot or serial number

All serial numbers.

Model or catalog number

939001

Companies
Manufacturer

Maquet Cardiopulmonary GmbH

Kehler Str. 31

Rastatt

76437

GERMANY