Agency classClass IIOur severity:Severe FDA (Devices)·Z-0276-2020·Announced 2019-11-13

Baxter Prismaflex Control Unit Recalled for Communication Error Alarms

Baxter Healthcare is recalling Prismaflex Control Units with software versions below 7.21 because communication error alarms 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' (FDA Class II with significant injury/property-damage reports or structural defects).

Plain-English summary

Baxter Healthcare Corporation is recalling 2,760 units of the Prismaflex Control Unit with software versions below 7.21. The recall involves Product Code 107493 and all lot numbers. The devices were distributed nationwide to 49 states and the District of Columbia, as well as internationally to numerous countries including those in Asia, the Americas, and the EMEA region.

The recall is due to a risk that 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 classified as an FDA Class II recall.

Healthcare facilities and users of these devices should contact Baxter Healthcare Corporation for instructions on how to address the issue. The source text does not specify a particular action for consumers, as the product is a medical device typically used in clinical settings.

The recalled product

Product: Prismaflex Control Unit, software versions below 7.21
Manufacturer: Baxter Healthcare Corporation
Category: Medical Device — Dialysis / Renal
Hazard: blood-loss
therapy-interruption
Affected units: 2,760

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: 107493
All Lot numbers
GTIN: 07332414073718

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