Agency classClass IIOur severity:High FDA (Devices)·Z-1278-2021·Announced 2021-03-31

Baxter Recalls Prismaflex Control Units Due to Tubing Performance Variability

Baxter Healthcare is recalling 1,225 Prismaflex Control Units used for Continuous 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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

Baxter Healthcare Corporation is recalling 1,225 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 within the ARPS (Automatic Repositioning System) Pump Assembly. This variability may lead to alarm situations occurring during or after a system self-test.

The affected units were distributed worldwide, including the United States (nationwide, Puerto Rico, and Guam) and numerous countries across Europe, Asia, Africa, the Americas, and Oceania. The specific serial numbers affected are listed in the agency's recall record Z-1278-2021.

Healthcare facilities and users of these devices should check their inventory against the list of affected serial numbers provided by the FDA. If a unit is affected, it should be removed from service and returned to Baxter Healthcare Corporation for repair or replacement as directed by the manufacturer.

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: 1,225

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 07332414105266 (product code 11308)
serial numbers PA9946
PA9945
PA9939
PA9938
PA9936
PA9935
PA9934
PA9933
PA9932
PA9931
PA9930
PA9929
PA9928
PA9926
PA9925
PA9924
PA9923
PA9922
PA9921

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