Device product
Bicarby Dialysate; Model number: RFP-400-G;
Z-2401-2026
Product summary
- Event
- Event 98892
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 4752
- Official record key
device-enforcement:Z-2401-2026
Official wording
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.
Code information: Model number: RFP-400-G; UDI-DI: 00840861102839; Lot codes: 25SG06026, 25SG06027;
Distribution pattern: Domestic: TX.
Derived failure modes
-
Unknown
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.