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