Prismaflex St100 SET US recall
PRISMAFLEX ST100 SET US, Product Code 107636US; Dialyzer, High Permeability With Or Without Sealed Dialysate System
Why was Prismaflex St100 SET US recalled?
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI/DI 00085412954073, All lots including and manufactured after 24G0072
- Product
- PRISMAFLEX ST100 SET US, Product Code 107636US; Dialyzer, High Permeability With Or Without Sealed Dialysate System
- Recalling firm
- VANTIVE US HEALTHCARE LLC
- Quantity
- 87,436 units
- Distribution
- US Nationwide distribution.
- Recall date
- February 11, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)