Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0085-2023·Announced 2022-10-19

Prismaflex HF20 Medical Device Recall Due to Mistranslated Instructions

Baxter Healthcare recalls the Prismaflex HF20 Set due to a mistranslation in device instructions that creates contradictory information about patient weight restrictions. The issue affects 29,764 devices distributed nationwide.

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: Class II FDA recall involving a labeling error (mistranslation) that creates contradictory information about a safety-relevant parameter (patient weight restrictions). No reported illnesses or injuries. The score reflects a correctable information discrepancy without demonstrated patient harm.

Plain-English summary

Baxter Healthcare Corporation is recalling the Prismaflex HF20 Set (product code 109841, UDI 07332414089443) used for continuous fluid management and renal replacement therapies. The recall affects 29,764 devices distributed nationwide.

The issue involves a mistranslation of the Estonian text in the device's Instructions for Use (IFU). The mistranslation creates contradictory information regarding patient body weight restrictions, which are important safety parameters for proper device operation.

No illnesses or injuries have been reported in connection with this recall. Patients and healthcare providers using affected devices should review corrected safety information and contact Baxter Healthcare for updated instructions.

The recalled product

Product: Prismaflex HF20 Set (product code 109841). For use in providing continuous fluid management and renal replacement therapies.
Manufacturer: Baxter Healthcare Corporation
Category: Medical Device — Renal Replacement Therapy
Hazard: mis-labeling
contradictory-instructions
Affected units: 29,764

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 (2)

UDI 07332414089443
All Lot Codes

Distribution

Distributed nationwide across the United States.

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

See all →

High
Baxter Recalls Likorall Overhead Lifts Due to Motor Shaft Breakage Risk
FDA (Devices) · 2026-10-21
Moderate
Baxter Recalls Two VOLARA Systems Due to Potential Flow Rate Inaccuracy
FDA (Devices) · 2026-09-30
Moderate
Baxter PRO+ 36-inch Mattress Recalled for UDI Labeling Error
FDA (Devices) · 2026-09-30
Moderate
Baxter PRO+ Mattress Recalled for UDI Labeling Error
FDA (Devices) · 2026-09-30
Moderate
Baxter Recalls PRO+ MRS Mattress Due to UDI Labeling Error
FDA (Devices) · 2026-09-30

Same hazard · mis labeling