FDA-Device2026-02-11Class IIPROCESSING DEFECT
Vantive Prismaflex M150 dialyzer sets recalled for deaeration chamber dislodgement risk
What this means
Vantive US Healthcare is recalling Prismaflex M150 dialyzer sets because the deaeration chamber may separate from the Prismaflex Control Unit during use. This could disrupt dialysis treatment. The recall affects units manufactured on or after June 24, 2024.
- Stop using affected Prismaflex M150 sets (Product Code 109990, UDI 07332414090005, lots from 24F0100CA onward)
- Contact your dialysis provider or Vantive immediately for guidance on replacement
- Do not resume dialysis with a recalled set until you receive a replacement
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
137,576 units
Manufactured in
510 Lake Cook Rd, N/A, Deerfield, IL, United States
Products
PRISMAFLEX M150 SET, Product Code 109990; Dialyzer, High Permeability With Or Without Sealed Dialysate System
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1228-2026Want us to check the next one for you?
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