fda_recall · device_recall · high
Fresenius Medical Care Holdings, Inc. — Class II recall: Bicarby" Dialysate; Model Numbers: RFP-400-G, RFP-401-G, RFP-402-G, RFP-404-G,…
- Event date
- 2026-06-17 00:00:00Z
- Observed
- 2026-07-09 22:52:14Z
- Source ID
- Z-2321-2026
- Payload hash
- ce1240b3495ad2d13c7fa6b0…
Summary
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… Status: Ongoing.
Entities
Informational only. Not legal, financial, or medical advice.