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.
What this means for you
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
- 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.
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