Fresenius Bicarby Dialysate recalled for luer-lock leak and slip hazard risk
What this means
Fresenius Medical Care is notifying users of potential leaks in Bicarby Dialysate products during setup and use. Fluid leaks from the luer-lock connection can create a slip and fall hazard on the floor where treatment is taking place.
- Check your dialysate product model number against the recall list (RFP-400-G, RFP-401-G, RFP-402-G, RFP-404-G, RFP-407-G, RFP-456-G).
- Contact Fresenius Medical Care or your healthcare provider for guidance on use or replacement.
- Be alert for leaks when preparing or handling the product and clean up any spilled fluid immediately.
The agency's original wording
Given the increased number of leaks reported by users, it was determined to be the appropriate course of action to notify users of the potential for the occurrence of Bicarby luer-lock leaks during manipulation of the frangible and tubing when preparing the product for use for treatment. This issue presents the potential of a slip and fall hazard associated with fluid on the floor.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2321-2026Want us to check the next one for you?
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