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.
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 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
- Hazard
- mis-labeling
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.
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