PrisMax V3 control Unit-US, Hemodialysis Delivery System, Product Code 955724
Summary
The FDA issued a Class II for PrisMax V3 control Unit-US, Hemodialysis Delivery System, Product Code 955724 by VANTIVE US HEALTHCARE LLC. Reason: Unexpected PrisMax System alarm T0830: Blood Leak Detected, when no blood leak is present, or difficulty normalizing the Blood Leak Detector (BLD) lea.
Details
Source
Device Recall
External ID
Z-2438-2025
Action Date
2025-09-03
Status
Ongoing
Category
device
Product Description
PrisMax V3 control Unit-US, Hemodialysis Delivery System, Product Code 955724
Lot/Code Info: UDI 07332414126018, All serial numbers
Quantity Affected: 2449 units
Reason for Recall
Unexpected PrisMax System alarm T0830: Blood Leak Detected, when no blood leak is present, or difficulty normalizing the Blood Leak Detector (BLD) leading to PrisMax System alarms T1313: BLD Normalize Failed, T0853: Normalization Failed, or T1205: BLD Self-Test Failure
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-2438-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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