Hemodialysis delivery systems recalled over priming alarm requiring additional priming cycles
PrisMax V2-US hemodialysis delivery systems are recalled because a low deaeration chamber level at post-priming tests may trigger alarm T2309, resulting in multiple additional priming cycles. 4,772 units are affected.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Rubric level 2 covers precautionary recalls; the stated consequence is repeated priming cycles rather than any described patient harm.
Plain-English summary
The PrisMax V2-US Hemodialysis Delivery System, product codes 955626, 955558, 955627 and 955701, UDI 00085412639499, is being recalled across all serial numbers. The recall covers 4,772 units distributed worldwide.
A 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. The FDA classified the action as Class II. The notice does not describe a patient consequence beyond the repeated priming.
Dialysis units operating these systems should follow the manufacturer's instructions for handling the alarm and for any corrective action.
The recalled product
- Product
- PrisMax V2-US, Hemodialysis Delivery System, Product Codes: 955626, 955558, 955627, 955701
- Manufacturer
- VANTIVE US HEALTHCARE LLC
- Category
- Medical Device — Dialysis
- Affected units
- 4,772
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI 00085412639499
- All Serial Numbers
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 3 recalled by VANTIVE US HEALTHCARE LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same manufacturer · VANTIVE US HEALTHCARE LLC
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