Fresenius Medical Care Holdings, Inc.: Bicarby Dialysate; Model number: RFP-400-G;

Hazard

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.

Details from the source

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: Domestic: TX. Quantity: 4752 Lot/code info: Model number: RFP-400-G; UDI-DI: 00840861102839; Lot codes: 25SG06026, 25SG06027;

UPC codes

00840861102839

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.