Bicarby" Dialysate; Model Numbers: RFP-400-G, RFP-401-G, RFP-402-G, RFP-404-G, RFP-407-G, and RFP-456-G;
Fresenius Medical Care Holdings, Inc.
The hazard
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. FDA Class II recall.
The remedy
Follow FDA guidance
About this recall
Bicarby" Dialysate; Model Numbers: RFP-400-G, RFP-401-G, RFP-402-G, RFP-404-G, RFP-407-G, and RFP-456-G;
Affected identifiers
Check these against the label on your unit. An identifier match is how a recall is confirmed, not just suspected.
Model Model Number: RFP-400-GModel UDI-DI: 00840861102839Model 2. Model Number: RFP-401-GModel UDI-DI: 00840861102853Model 3. Model Number: RFP-402-GModel UDI-DI: 00840861102822Model 4. Model Number: RFP-404-GModel UDI-DI: 00840861102914Model 5. Model Number: RFP-407-GModel UDI-DI: 00840861102846: 6. Model Number: RFP-456-GModel UDI-DI: 00840861102945Model All lots produced from January 13Model 2025Model through lot 26AG02019 on January 13Model 2026UPC 00840861102839UPC 00840861102853UPC 00840861102822UPC 00840861102914UPC 00840861102846UPC 00840861102945Would you have heard about this one?
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