Agency classClass IIOur severity:High FDA (Devices)·Z-0082-2023·Announced 2022-10-19

Prismaflex M Set Medical Device Recalled Due to Instruction Mistranslation

Baxter Healthcare is recalling 334,932 Prismaflex M Set M150 devices due to a mistranslation in instructions that creates 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 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: FDA Class II medical device recall with no reported illnesses or injuries. The mistranslation involves safety-critical information about patient body weight restrictions in a renal replacement therapy device, constituting a risk-of-harm situation without yet-reported injury.

Plain-English summary

Baxter Healthcare Corporation is recalling the Prismaflex M Set M150, a medical device used for continuous fluid management and renal replacement therapy. The recall affects 334,932 devices distributed nationwide.

The Prismaflex M Set's instructions for use contain a mistranslation of the Estonian text that provides contradictory information about patient body weight restrictions. This mistranslation could potentially affect how healthcare providers understand and apply the device's proper usage guidelines.

Healthcare facilities and clinicians using or stocking these devices should contact Baxter Healthcare Corporation for clarification regarding the correct information about patient weight restrictions and the proper use of the device.

The recalled product

Product: Prismaflex M Set: M150 (product code 109990). For use in providing continuous fluid management and renal replacement therapies.
Manufacturer: Baxter Healthcare Corporation
Category: Medical Device — Renal Replacement Therapy
Hazard: mis-labeling
Affected units: 334,932

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 07332414090005
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

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Same hazard · mis labeling