Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1279-2021·Announced 2021-03-31

Baxter Recalls Prismaflex Control Units Due to Tubing Performance Variability

Baxter Healthcare is recalling 1,650 Prismaflex Control Units used for renal replacement therapy because tubing performance variability may cause alarms during or after system self-tests.

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: The recall is classified as FDA Class II, and the source text does not report any illnesses or injuries, fitting the criteria for a moderate severity score involving a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Baxter Healthcare Corporation is recalling 1,650 units of the Prismaflex Control Unit, a medical device used for Continuous Renal Replacement Therapy (CRRT). The recall is due to variability in the performance of the tubing in the Automatic Repositioning System (ARPS) Pump Assembly. This variability may lead to alarm situations during or after a system self-test.

The affected units were distributed worldwide, including nationwide in the United States (including Puerto Rico and Guam) and in numerous countries across Europe, Asia, Africa, and the Americas. The recall covers specific serial numbers associated with GTINs 07332414117702, 07332414124236, and 07332414126766.

Hospitals and healthcare facilities should check their inventory for the affected serial numbers and contact Baxter Healthcare for instructions on how to proceed. The source text does not report any illnesses or injuries associated with this recall.

The recalled product

Product: Prismaflex Control Unit - Product Usage: Used for Continuous Renal Replacement Therapy (CRRT).
Manufacturer: Baxter Healthcare Corporation
Category: Medical Device — Renal Replacement Therapy
Hazard: device-malfunction
false-alarm
Affected units: 1,650

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 (20)

GTIN 07332414117702 (product code 115269)
serial numbers PA18954
PA18949
PA18948
PA18947
PA18946
PA18945
PA18944
PA18943
PA18941
PA18939
PA18937
PA18936
PA18935
PA18934
PA18932
PA18931
PA18930
PA18927
PA18926

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Part of a larger recall action

This product is one of 4 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 4 products in this recall →

Same manufacturer · Baxter Healthcare Corporation

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Same hazard · device malfunction