FDA Medical devices recall ·
Bicarby Dialysate recall
- Recall number
- Z-2401-2026
- Date
- (initiated May 7, 2026)
- Company / brand
- Fresenius Medical Care Holdings, Inc.
920 Winter St Bld 920, Waltham, MA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 4752
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Bicarby Dialysate; Model number: RFP-400-G;
Why was it recalled?
There is an error in the labeling of the GTIN on the product. When scanned; however, the case labeling, lot number, and printed labeling on the product correctly identifies the product code and the solution contained in the bag. In the event the incorrect GTIN labeling is used as the singular source for product identification, unrecognized use of a potassium solution with a concentration differing from the prescription may result.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Model number: RFP-400-G; UDI-DI: 00840861102839; Lot codes: 25SG06026, 25SG06027;
Distribution
Domestic: TX.
States: Texas
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2401-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.