Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1277-2021·Announced 2021-03-31

Baxter Recalls Prismaflex Control Units Due to Tubing Performance Variability

Baxter Healthcare is recalling Prismaflex Control Units because tubing variability may cause alarms during self-tests. The units are used for Continuous Renal Replacement Therapy.

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. The hazard is described as leading to alarm situations, which is a functional defect without explicit reports of injury or death, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Baxter Healthcare Corporation is recalling 4,946 units of the Prismaflex Control Unit. These devices are 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 performance variability may lead to alarm situations during or after a system self-test. The affected units were distributed worldwide, including in the United States, Puerto Rico, Guam, and numerous international locations.

Healthcare facilities and users should stop using the affected Prismaflex Control Units and contact Baxter Healthcare Corporation for instructions on how to proceed with the recall.

The recalled product

Product: Prismaflex Control Unit - Product Usage: Used for Continuous Renal Replacement Therapy (CRRT).
Manufacturer: Baxter Healthcare Corporation
Category: Medical Device — Dialysis Equipment
Hazard: device-malfunction
false-alarm
Affected units: 4,946

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 07332414073718 (Product code 107493)
serial numbers PA0105
PA0104
PA0106
PA0102
PA0107
PA0112
PA0111
PA0117
PA0113
PA0120
PA0127
PA0124
PA0130
PA0132
PA0131
PA0134
PA0128
PA0136
PA0141

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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