Agency classClass IIOur severity:Severe FDA (Devices)·Z-0277-2020·Announced 2019-11-13

Baxter Prismaflex Control Unit Recalled for Potential Therapy Interruption

Baxter Healthcare is recalling Prismaflex Control Units with software below version 7.21 due to communication errors that may interrupt therapy or cause blood loss.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves a risk of blood loss and therapy interruption, which aligns with the rubric criteria for Severe severity involving significant injury reports or high-risk medical device defects.

Plain-English summary

Baxter Healthcare Corporation is recalling 986 units of the Prismaflex Control Unit, specifically those running software versions below 7.21. The recall involves Product Code 113081 and all lot numbers. The devices were distributed nationwide to numerous U.S. states and territories, as well as internationally to countries in Asia, the Americas, and the EMEA region.

The recall is issued because communication error alarms may result in the interruption of therapy, a delay in therapy, or blood loss due to the non-restitution of blood in the extracorporeal circuit. This is a Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

Healthcare facilities and users of these devices should contact Baxter Healthcare Corporation for instructions on how to address the software issue and ensure patient safety.

The recalled product

Product: Prismaflex Control Unit, software versions below 7.21
Manufacturer: Baxter Healthcare Corporation
Category: Medical Device — Dialysis Equipment
Hazard: blood-loss
therapy-interruption
Affected units: 986

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 (3)

Product Code: 113081
All Lot numbers
GTIN: 07332414105266

Distribution

Distributed nationwide across the United States.

The notice also names 50 states specifically:

Part of a larger recall action

This product is one of 5 recalled by Baxter Healthcare Corporation 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 5 products in this recall →

Same manufacturer · Baxter Healthcare Corporation

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Same hazard · blood loss