- Recalling firm
- Fresenius Medical Care Holdings, Inc.
- Reason for recall
- 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.
- Affected products (lot / model / serial)
- Model number: RFP-400-G; UDI-DI: 00840861102839; Lot codes: 25SG06026, 25SG06027;
- Units affected
- 4752
- Distribution pattern
- Domestic: TX.
- Firm location
- Waltham, MA, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-2401-2026
- Recall initiated
- May 7, 2026
- FDA classification date
- June 11, 2026
- FDA report date
- June 17, 2026
- FDA event ID
- 98892
- Last updated on HTM Vibe
- July 23, 2026