Fresenius Medical Care Holdings, Inc.: Dialysate Concentrate For Hemodialysis (liquid Or Powder)
Recall Summary Fresenius Medical Care is recalling Bicarby Dialysate (Model RFP-400-G) distributed in Texas due to incorrect barcode labeling on the packaging. While the actual product inside is correctly labeled, the barcode may not scan to the right product information. If the barcode is the only way staff identifies the product, there's a risk of using a dialysate with a potassium level different from what was prescribed.
- Recalling firm
- Fresenius Medical Care Holdings, Inc.
- Product
- Bicarby Dialysate; Model number: RFP-400-G;
- Reason
- 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.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-05-07
- Status
- Open, Classified
- Areas affected
- TX
- Distribution
- Domestic: TX.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/775aae10-0264-40bc-a9b9-e8f563252015