Health product recall

Hemoconcentrator Set (2020-11-05)

Starting date:
November 5, 2020
Posting date:
November 20, 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-74353



Last updated:
2020-11-19

Affected Products

Hemoconcentrator Set

Reason

Some quarantined tubing sets with a hemoconcentrator have been released to the market. The products were subjected to an unknown storage temperature for two days during transportion to the distribution center. Taking into consideration the product risks due to storage at temperature higher then recommended, the following potential health consequences (harms) could occur:

- ischemia, infection, user inconvenience.

Affected products

Hemoconcentrator Set

Lot or serial number

92262563

92262567

92283141

Model or catalog number

H 52570

H 52571

H 55070

Companies
Manufacturer

Maquet Cardiopulmonary GmbH

Kehler Str. 31

Rastatt

76437

GERMANY