PrisMax Control Unit (2021-01-13)
- Starting date:
- January 13, 2021
- Posting date:
- January 29, 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-74877
Last updated:
2021-01-29
Affected Products
PrisMax Control Unit
Reason
Baxter Corporation is issuing an urgent medical device correction to the users of the Prismax control unit, due to the variability in performance of the tubing in the ARPS (automatic repositioning system) pump assembly which may lead to alarm situations during a system self-test and during therapy.
Affected products
PrisMax Control Unit
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
955558
Companies
- Manufacturer
-
Baxter Healthcare SA
PO BOX 8010
Zurich
8010
SWITZERLAND