Prismaflex HF20 Set recall
Prismaflex HF20 Set (product code 109841). For use in providing continuous fluid management and renal replacement therapies.
Why was Prismaflex HF20 Set recalled?
Within the current Prismaflex set IFU (instructions for use), there is a mistranslation of the Extonian (Eesti) text. The mistranslation indicates contradictory information related to the patient body weight restrictions.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI 07332414089443, All Lot Codes
- Product
- Prismaflex HF20 Set (product code 109841). For use in providing continuous fluid management and renal replacement therapies.
- Recalling firm
- Baxter Healthcare Corporation
- Quantity
- 29,764 devices
- Distribution
- US Nationwide
- Recall date
- October 19, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)