The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0083-2023·Announced 2022-10-19

Prismaflex HF medical device sets recalled for instructional mistranslation

Baxter Healthcare recalls Prismaflex HF Set devices due to a mistranslation in Estonian language instructions. The mistranslation contains contradictory information about patient body weight restrictions.

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: This is an FDA Class II labeling defect involving a mistranslation in device instructions. No illnesses, injuries, or deaths have been reported. The issue is a correctable instructional error, though it affects safety-critical weight restriction information.

Plain-English summary

Baxter Healthcare Corporation is recalling 328,300 Prismaflex HF Set devices (models HF1000 and HF1400) distributed nationwide in the United States. These devices are used to provide continuous fluid management and renal replacement therapies.

The recall addresses a mistranslation in the Estonian language text within the Instructions for Use (IFU). The mistranslated text contains contradictory information related to patient body weight restrictions, which are critical safety parameters for proper device use.

Healthcare facilities and clinicians currently using these devices should review the updated instructions from Baxter Healthcare. Corrected documentation clarifies the intended weight restriction guidelines to ensure safe patient treatment.

The recalled product

Product
Prismaflex HF Set: HF1000 (product code 107140), HF1400 (product code 107142). For use in providing continuous fluid management and renal replacement therapies.
Manufacturer
Baxter Healthcare Corporation
Category
Medical Device — Renal Replacement Therapy Equipment
Hazard
Affected units
328,300

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)

  • UDI 07332414069254 (product code 107140)
  • 07332414069315 (product code 107142)
  • 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 →

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