PRISMAFLEX Hemodialysis Unit recall in Canada: malfunction alarm
In plain language
This recall involves PRISMAFLEX Hemodialysis Units sold in Canada. It's being recalled because a potential pump module electronics failure could cause a "voltage out of range" malfunction alarm. Baxter Corporation will be installing new firmware to address this issue.
What to do
- Contact Baxter Corporation for firmware installation.
- Follow all instructions provided by Baxter Corporation.
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Affected products
PRISMAFLEX HEMODIALYSIS UNIT
Model: 107493-6023014700
Lot: All serial numbers
PRISMAFLEX WITH SOFTWARE RELEASE 4.00
Model: 113082
Lot: All serial numbers
PRISMAFLEX WITH SOFTWARE 5.00
Model: 113874
Lot: All serial numbers
PRISMAFLEX WITH SOFTWARE 6.10
Model: 114489
Lot: All serial numbers
PRISMAFLEX WITH SOFTWARE 7.10
Model: 114870
Lot: All serial numbers
PRISMAFLEX WITH SOFTWARE 8.10
Model: 955052
Lot: All serial numbers
Why this matters
Malfunction alarm
Do I have this product?
This recall only applies to specific products. Follow the steps below to check.
- 1
Check the product name
Make sure your product name matches one of the affected products listed above.
- 2
Check the lot number
Lot numbers identify specific production batches.
Affected lots: All serial numbers
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: 107493-6023014700, 113082, 113874, 114489, 114870, 955052
If your product matches one or more of the details above, it may be affected by this recall.
If your product does not match these details, it is not affected by this recall.
When in doubt, always check the official notice.
Frequently Asked Questions
Why was this product recalled?
Malfunction alarm
What should consumers do?
Contact Baxter Corporation for firmware installation. Follow all instructions provided by Baxter Corporation.
Where was the product sold?
This product was sold in Canada. For specific retailers or distribution areas, please check the official recall notice linked on this page.
Is there a health risk?
Yes, there may be a health risk. Malfunction alarm
When was this product recalled?
This product was recalled on June 1, 2018.
Is the PRISMAFLEX brand affected by this recall?
Yes, PRISMAFLEX products are affected by this recall. This recall involves PRISMAFLEX Hemodialysis Units sold in Canada. It's being recalled because a potential pump module electronics failure could cause a "voltage out of range" malfunction alarm. Baxter Corporation will be installing new firmware to address this issue.