Agency classClass IIOur severity:Severe FDA (Devices)·Z-0278-2020·Announced 2019-11-13

Baxter Prismaflex Control Unit Software Recall for Therapy Interruption Risk

Baxter 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 risks or Class II classifications with potential for serious harm.

Plain-English summary

Baxter Healthcare Corporation is recalling 988 units of the Prismaflex Control Unit with software versions below 7.21. The recall is due to a defect where communication error alarms may result in the interruption or delay of therapy, or blood loss due to the non-restitution of blood in the extracorporeal circuit.

The affected devices were distributed nationwide to 48 states and the District of Columbia, as well as internationally to numerous countries including those in Asia, the Americas, and Europe. The product code is 114870, and the recall applies to all lot numbers.

Healthcare facilities and users should contact Baxter Healthcare Corporation for instructions on how to address the software defect 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: 988

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: 114870
All Lot numbers
GTIN: 07332414115395. Device not distributed in the US.

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