PRIMSAFLEX M100 SET, Product Code 106697; Dialyzer, High Permeability With Or Without Sealed Dialysate System
Summary
The FDA issued a Class II for PRIMSAFLEX M100 SET, Product Code 106697; Dialyzer, High Permeability With Or Wi by VANTIVE US HEALTHCARE LLC. Reason: There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit..
Details
Source
Device Recall
External ID
Z-1227-2026
Action Date
2026-02-11
Status
Ongoing
Category
device
Product Description
PRIMSAFLEX M100 SET, Product Code 106697; Dialyzer, High Permeability With Or Without Sealed Dialysate System
Lot/Code Info: UDI/DI 07332414064556, All lots including and manufactured after 24F0077CA
Quantity Affected: 230,596 units
Reason for Recall
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
Distribution
US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-01-06
Company
Deerfield, IL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 207 device recalls issued in the same week, part of 403 device-related FDA actions this month.
VANTIVE US HEALTHCARE LLC has 13 FDA actions in our database, including 12 recalls and 1 clearance.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (VANTIVE US HEALTHCARE LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does VANTIVE US HEALTHCARE LLC have FDA actions?
VANTIVE US HEALTHCARE LLC has 13 FDA actions in our database, including 12 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1227-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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