Bicarby RFP-404-GRecalls & reported problems

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

1 other recall cover devices cleared under the same FDA submission (K243786); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. May 12, 2026Open, Classified

   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.

   Z-2321-2026 · Root cause: Process design · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K243786. One submission often covers many models, so check the product and lot details in each record.

• Z-2401-2026 · May 7, 2026 · Open, Classified
  Bicarby Dialysate; Model number: RFP-400-G;