[pending] Bicarby Dialysate; Model number: RFP-400-G;
Pending LLM rewrite. Source: FDA_DEVICE Z-2401-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
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.
The recalled product
- Product
- Bicarby Dialysate; Model number: RFP-400-G;
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Model number: RFP-400-G
- UDI-DI: 00840861102839
- Lot codes: 25SG06026
- 25SG06027
Distribution
Distributed in 1 state:
- TX
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