FDA-Device2026-02-11Class IIPROCESSING DEFECT
Vantive Prismaflex ST150 dialyzer set recalled for deaeration chamber dislodgement risk
What this means
Vantive US Healthcare has recalled Prismaflex ST150 dialyzer sets because the deaeration chamber may become loose and detach from the control unit during use. This affects units manufactured on or after June 24, 2025. No injuries have been reported.
- Check if you have a Prismaflex ST150 set with Product Code 107640US manufactured after lot 24F0085
- Stop using affected units immediately
- Contact Vantive US Healthcare or your dialysis center for instructions on replacement or proper disposal
- Have your healthcare provider assess your dialysis setup to ensure safety
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
264,040 units
Manufactured in
510 Lake Cook Rd, N/A, Deerfield, IL, United States
Products
PRISMAFLEX ST150 SET US, Product Code 107640US; Dialyzer, High Permeability With Or Without Sealed Dialysate System
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1225-2026Want us to check the next one for you?
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