PrisMax V2-US, Hemodialysis Delivery System, Product Codes: 955626, 955558, 955627, 955701
Summary
The FDA issued a Class II for PrisMax V2-US, Hemodialysis Delivery System, Product Codes: 955626, 955558, 955 by VANTIVE US HEALTHCARE LLC. Reason: Low deaeration chamber level at post priming tests may lead to PrisMax System alarm T2309: Air Detected in Prime resulting in multiple additional prim.
Details
Source
Device Recall
External ID
Z-2437-2025
Action Date
2025-09-03
Status
Ongoing
Category
device
Product Description
PrisMax V2-US, Hemodialysis Delivery System, Product Codes: 955626, 955558, 955627, 955701
Lot/Code Info: UDI 00085412639499, All Serial Numbers
Quantity Affected: 4772 units
Reason for Recall
Low deaeration chamber level at post priming tests may lead to PrisMax System alarm T2309: Air Detected in Prime resulting in multiple additional priming cycles
Distribution
Worldwide
Type: Voluntary: Firm initiated
Recall Initiated: 2025-07-28
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 201 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-2437-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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