FDA-Device2026-02-11Class IIPROCESSING DEFECT
Vantive OXIRIS dialyzer sets recalled for deaeration chamber dislodgement risk
What this means
Vantive US Healthcare is recalling certain OXIRIS dialyzer sets because a part called the deaeration chamber may come loose from the Prismaflex Control Unit during use. This could interrupt dialysis treatment. No injuries have been reported so far.
- If you use an OXIRIS dialyzer set (Product Code 112016), stop using it and contact your dialysis clinic or healthcare provider right away
- Check if your set's manufacturing date is on or after 24G0041Z by looking at the product label
- Ask your provider about replacement equipment and continued treatment options
The agency's original wording
Hazard
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution.
Affected count
2,724 units
Manufactured in
510 Lake Cook Rd, N/A, Deerfield, IL, United States
Products
OXIRIS SET, Product Code 112016; Dialyzer, High Permeability With Or Without Sealed Dialysate System
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1226-2026Want us to check the next one for you?
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