Prismaflex ST Renal Therapy Sets Recalled for Mistranslated Safety Instructions
Baxter Healthcare is recalling 1,068,560 Prismaflex ST renal replacement therapy sets nationwide. The recall is due to a mistranslation in the Estonian instructions that contains contradictory information about patient weight restrictions.
What this means for you
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 device with mistranslated safety instructions affecting critical weight-restriction parameters. This constitutes a risk-of-harm product where the hazard is theoretical with no reported illnesses or injuries, meeting the High severity criterion.
Plain-English summary
Baxter Healthcare Corporation is recalling the Prismaflex ST Set (product codes 107643, 107636, 107640), which are used for continuous fluid management and renal replacement therapies. The recall affects 1,068,560 devices distributed nationwide.
The recall is due to a mistranslation in the Estonian-language version of the instructions for use provided with the device. This mistranslation includes contradictory information regarding patient body weight restrictions, which are critical safety parameters for proper device use.
The correct weight restriction information is contained in the English-language instructions for use. Healthcare facilities and providers using these devices should refer to the English-language instructions to ensure proper treatment parameters.
The recalled product
- Product
- Prismaflex ST Set: ST60 (product code 107643), ST100 (product code 107636), ST150 (product code 107640). For use in providing continuous fluid management and renal replacement therapies.
- Manufacturer
- Baxter Healthcare Corporation
- Hazard
- mis-translation
- contradictory-instructions
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 (4)
- UDI: 07332414075682 (product code 107643)
- 07332414075613 (product code 107636)
- 07332414075651 (product code 107640)
- All Lot Codes
Distribution
Distributed nationwide across the United States.
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