Health product recall

Prismaflex Hemodialysis Unit (2020-03-30)

Starting date:
March 30, 2020
Posting date:
April 8, 2020
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type I
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-72697

Last updated: 2020-06-15

Affected Products

  1. Prismaflex Hemodialysis Unit
  2. Prismaflex With Software Release 4.00
  3. Prismaflex With Software 6.10
  4. Prismaflex With Software 7.10

Reason

Manufacturer received questions from clinicians exploring modifying their use of Prismaflex Hemodialysis Unit, in order to minimize exposure to COVID-19-positive patients. For example, clinicians may be using multiple extension lines to extend the length of the tubing set to allow placement of a Prismaflex Hemodialysis Unit outside of the patient's room. As per manufacturer, several significant risks could arise with this practice. To mitigate these risks, manufacturer is recommending following the setup instructions in the graphical user interface, as well as the warnings from the Prismaflex operators manual. Failure to do so could result in serious patient harm.

Affected products

A. Prismaflex Hemodialysis Unit

Lot or serial number

All lots.

Model or catalog number

107493-6023014700

Companies
Manufacturer
Gambro Lundia AB
MAGISTRATSVAGEN 16, P.O. BOX 10101,
Lund
22010
SWEDEN

B. Prismaflex with Software Release 4.00

Lot or serial number

All lots.

Model or catalog number

113082

Companies
Manufacturer
Gambro Lundia AB
MAGISTRATSVAGEN 16, P.O. BOX 10101,
Lund
22010
SWEDEN

C.  Prismaflex with Software 6.10

Lot or serial number

All lots.

Model or catalog number

114489

Companies
Manufacturer
Gambro Lundia AB
MAGISTRATSVAGEN 16, P.O. BOX 10101,
Lund
22010
SWEDEN

D. Prismaflex with Software 7.10

Lot or serial number

All lots.

Model or catalog number

114870

Companies
Manufacturer
Gambro Lundia AB
MAGISTRATSVAGEN 16, P.O. BOX 10101,
Lund
22010
SWEDEN

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