Prismaflex M Set: M60 recall
Prismaflex M Set: M60 (product code 106696), M100 (product code 106697). For use in providing continuous fluid management and renal replacement…
Why was Prismaflex M Set: M60 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: 07332414064549 (product code 106696), 07332414064556 (product code 106697); All lot codes
- Product
- Prismaflex M Set: M60 (product code 106696), M100 (product code 106697). For use in providing continuous fluid management and renal replacement…
- Recalling firm
- Baxter Healthcare Corporation
- Quantity
- 524,376 devices
- Distribution
- US Nationwide
- Recall date
- October 19, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)