FDA Medical Device Recalls (openFDA)
VANTIVE US HEALTHCARE LLC: OXIRIS SET, Product Code 112016; Dialyzer, High Permeability With Or Without Sealed Dialysate System
- Recall number
- Z-1226-2026
- Recalling firm
- VANTIVE US HEALTHCARE LLC
- Product
- OXIRIS SET, Product Code 112016; Dialyzer, High Permeability With Or Without Sealed Dialysate System
- Status
- Open, Classified
- Initiated
- 2026-01-06
- Posted
- 2026-02-02
- Terminated
- not on file
- 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 position, please consider the following: . Ensure there are no kinks in the tubing and that the deaeration chamber remains visible. . If the Prismaflex Control Unit issues an Air in Blood alarm, check if air is present. If there is no air present, check if the deaeration chamber is dislodged from the holder and ensure there are no clots present. 1. If no dislodgement, please follow the operator s manual instructions for Air in Blood alarm. 2. In case of dislodgement with clotting, follow the associated instructions within the Prismaflex Control Unit operator s manual to stop the therapy and replace the set. 3. Only in case of dislodgement without clotting or any other alarms, if the chamber is secured in an upright position, follow the associated instructions within the Prismaflex Control Unit operator s manual to proceed with treatment. Facilities who further distributed the products were directed to notify those departments or facilities. Dealers, wholesalers, distributor/resellers, or original equipment manufacturers (OEM) who further distributed the products were directed to notify their customers. For general questions regarding this communication, please contact Vantive Customer Care at 833-542-CRRT (2778). Vantive Customer Care is available 24 hours a day, seven days a week.
- Quantity
- 2,724 units
- Distribution
- US Nationwide distribution.
- Lot, serial or model codes
- UDI/DI 07332414102234, All lots including and manufactured after 24G0041Z
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KDI
- Firm FEI
- 3038195011
- Firm city
- Deerfield
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28