FDA-Device2026-02-11Class IIPROCESSING DEFECT
Vantive Prismaflex ST100 dialyzer set recalled for deaeration chamber dislodgement risk
What this means
The deaeration chamber in certain Vantive Prismaflex ST100 dialyzer sets may detach from the control unit during use. This could interrupt treatment. The recall affects units manufactured on or after lot 24G0072.
- Stop using Prismaflex ST100 sets with lot number 24G0072 or later
- Contact your dialysis provider or Vantive immediately to report which lots your facility uses
- Request replacement sets or use alternative products until your supply is confirmed safe
- Follow your healthcare provider's guidance on treatment continuity during the transition
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
87,436 units
Manufactured in
510 Lake Cook Rd, N/A, Deerfield, IL, United States
Products
PRISMAFLEX ST100 SET US, Product Code 107636US; Dialyzer, High Permeability With Or Without Sealed Dialysate System
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1224-2026Want us to check the next one for you?
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