Fresenius Medical Care Holdings, Inc. Recalls
4 recalls on record in the United States
Fresenius Medical Care Holdings, Inc. recalls DELFLEX, Dextrose Peritoneal Dialysis Solution with attached
Lack of Assurance of Sterility: Potential leaks from perforations in bags.
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Fresenius Medical Care Holdings, Inc. recalls DELFLEX, Dextrose Peritoneal Dialysis Solution with attached
Lack of Assurance of Sterility: Potential leaks from perforations in bags.
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Fresenius Medical Care Holdings, Inc. recalls 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.
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Fresenius Medical Care Holdings, Inc. recalls Bicarby" Dialysate; Model Numbers: RFP-400-G, RFP-401-G, RF
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.
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