Health product recall

Prismaflex Control Unit (2020-02-13)

Starting date:
February 13, 2020
Posting date:
December 11, 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-74507



Last updated:
2020-12-10

Affected Products

A. Prismaflex Control Unit

B. Prismaflex Control Unit

C. Prismaflex Control Unit

D. Prismaflex Control Unit

Reason

Baxter Corporation is communicating important safety information regarding the use of connectors with the Prismaflex Control Unit. The use of connectors may prevent a secure connection between the return line and the patient's blood access device.

Affected products

A. Prismaflex Control Unit

Lot or serial number

All serial numbers.

Model or catalog number

107493

Companies
Manufacturer

Gambro Lundia AB

MAGISTRATSVAGEN 16, P.O. BOX 10101,

Lund

22010

SWEDEN


B. Prismaflex Control 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 Control 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 Control 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