Prismaflex Hemodialysis Unit (2021-02-03)
- Starting date:
- February 3, 2021
- Posting date:
- February 26, 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-75049
Last updated:
2021-02-26
Affected Products
A. Prismaflex Hemodialysis Unit
B. Prismaflex Hemodialysis Unit
C. Prismaflex Hemodialysis Unit
D. Prismaflex Hemodialysis Unit
Reason
Baxter Corporation is issuing an urgent medical device correction to the user level for the Prismaflex Hemodialysis Unit due to variability in the performance of the tubing in the ARPS (Automatic Repositioning System) pump assembly, which may lead to alarm during or after a system self-test.
Affected products
A. Prismaflex Hemodialysis Unit
Lot or serial number
All serial numbers.
Model or catalog number
107493-6023014700
Companies
- Manufacturer
-
Gambro Lundia AB
MAGISTRATSVAGEN 16, P.O. BOX 10101,
Lund
22010
SWEDEN
B. Prismaflex Hemodialysis Unit
Lot or serial number
All serial numbers.
Model or catalog number
113082
Companies
- Manufacturer
-
Gambro Lundia AB
MAGISTRATSVAGEN 16, P.O. BOX 10101,
Lund
22010
SWEDEN
C. Prismaflex Hemodialysis Unit
Lot or serial number
All serial numbers.
Model or catalog number
114489
Companies
- Manufacturer
-
Gambro Lundia AB
MAGISTRATSVAGEN 16, P.O. BOX 10101,
Lund
22010
SWEDEN
D. Prismaflex Hemodialysis Unit
Lot or serial number
All serial numbers.
Model or catalog number
114870
Companies
- Manufacturer
-
Gambro Lundia AB
MAGISTRATSVAGEN 16, P.O. BOX 10101,
Lund
22010
SWEDEN