FDA-Device2026-02-11Class IIPROCESSING DEFECT
Vantive Prismaflex HF1000 dialyzer set recalled for deaeration chamber dislodgement risk
What this means
Vantive US Healthcare is recalling Prismaflex HF1000 dialyzer sets because the deaeration chamber may come loose from the Prismaflex Control Unit during use. This affects units manufactured on or after lot 24G0034CA. No injuries have been reported.
- Check your Prismaflex HF1000 set lot number against lot 24G0034CA and later
- Stop using affected units immediately
- Contact Vantive US Healthcare or your healthcare provider for replacement units or instructions
- Report any problems to the FDA MedWatch program
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
93,576 units
Manufactured in
510 Lake Cook Rd, N/A, Deerfield, IL, United States
Products
PRISMAFLEX HF1000 SET, Product Code 107140; Dialyzer, High Permeability With Or Without Sealed Dialysate System
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1229-2026Want us to check the next one for you?
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