Z-2401-2026 Class II Ongoing
FDA device recall Z-2401-2026 was initiated by Fresenius Medical Care Holdings, Inc. on May 7, 2026 and is designated Class II. 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 so… The recall status is ongoing. Affected quantity: 4752.
Recall Details
- Product Type
- Devices
- Report Date
- June 17, 2026
- Initiation Date
- May 7, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4752
Product Description
Bicarby Dialysate; Model number: RFP-400-G;
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.
Distribution Pattern
Domestic: TX.
Code Information
Model number: RFP-400-G; UDI-DI: 00840861102839; Lot codes: 25SG06026, 25SG06027;