Recall Z-1227-2026 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
VANTIVE US HEALTHCARE LLC
PRIMSAFLEX M100 SET, Product Code 106697; Dialyzer, High Permeability With Or Without Sealed Dialysate System
| Date | Feb 2, 2026 (initiated Jan 6, 2026) |
| Status | Open, Classified |
| Reason | There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit. |
| Root cause | Component design/selection |
| Action | Vantive issued an Urgent Medical Device Correction notice to its consignees on 01/06/2026 via USPS first class mail. The notice explained the issue, hazard involved, and requested the following: 1. You may continue to perform therapy using the Prismaflex sets listed above. Please monitor the deaeration chamber during therapy to ensure it remains in an upright position within the holder. 2. Vantive is aware of customers who have experienced this issue and attempted to further secure the deaeration chamber in an upright position. If attempting to secure the deaeration chamber in an upright |
| Quantity | 230,596 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K041005 | GAMBRO PRISMAFLEX AND GAMBRO PRISMAFLEX M60 & M100 SETS Gambro Renal Products, Oct 7, 2004 |