Health product recall

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