Dialysate Concentrate For Hemodialysis (liquid Or Powder)

Bicarby Dialysate; Model number: RFP-400-G;

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.

Bicarby" Dialysate;

Given the increased number of leaks reported by users, it was determined to be the appropriate course of action to notify users of the potential for the occurrence of Bicarby luer-lock leaks during manipulation of the frangible and tubing when preparing the product for use for treatment. This issue presents the potential of a slip and fall hazard associated with fluid on the floor.

Brand Name: Diasol

Safety and efficacy of dialysis acid concentrate cannot be assured

Brand Name: Diasol

Safety and efficacy of dialysis acid concentrate cannot be assured

Brand Name: Diasol

Safety and efficacy of dialysis acid concentrate cannot be assured

Brand Name: Diasol

Safety and efficacy of dialysis acid concentrate cannot be assured

Brand Name: Diasol

Safety and efficacy of dialysis acid concentrate cannot be assured

Brand Name: Diasol

Safety and efficacy of dialysis acid concentrate cannot be assured

NxStage PureFlow-B Solution. Catalog numbers: RFP-400, RFP-401, RFP-402, RFP-403, RFP-404, RFP-406, RFP-453, RFP-454, RFP-456.

Potential for the perimeter seal on the small chamber of the two-chamber bag to fail causing the electrolyte fluid to splash into the face of the user when attempting to open the peel seam to mix the two chambers prior to treatment.

MedicaLyte Liquid Bicarbonate Concentrate. Model Numbers: BC+201 (45X), BC+100 36.83X.

Potential for the presence of visible foreign matter.