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U.S. Department of Health and Human Services

Medical Device Recalls
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Related Medical Device Recalls
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Z-2082-2021 - (1) 08-4078-BB BIBAG 650 GRAMS/BAG 16 BAGS/CASE (2) 08-4080-BB BIBAG 900 grams/bag 12 bags/case For patients with acute and chronic end stage renal disease going under PD in healthcare or home... 2 07/16/2021 Fresenius Medical Care Holdings, Inc.
Z-2083-2021 - The Drain Bag Set (tubings and flexible bags) is a passive, closed drainage system used as an optional receptacle during an APD treatment. The Drain Bag Set is used to collect effluent in bags rather ... 2 07/16/2021 Fresenius Medical Care Holdings, Inc.
Z-2084-2021 - Citrasate Dry Acid Concentrate and GranuFlo Dry Acid Concentrate are each intended to be used as one component in the preparation of dialysate in a 3-stream proportioning hemodialysis machine accordin... 2 07/16/2021 Fresenius Medical Care Holdings, Inc.
Z-2085-2021 - 026-20036A Liberty Drain Line, Luer Tap For patients with acute and chronic end stage renal disease going under PD in healthcare or home setting 2 07/16/2021 Fresenius Medical Care Holdings, Inc.
Z-2090-2021 - 050-95012 Sterile Stay Safe Cap The Indications for Use/Intended Use for the Fresenius Sterile Stay Safe® Cap is equivalent to that for the Fresenius Stay Safe Cap and is as follows: Indications for ... 2 07/16/2021 Fresenius Medical Care Holdings, Inc.
Z-2087-2021 - NaturaLyte Dry Bicarbonate Concentrate is composed of sodium bicarbonate powder and is used as one component in the preparation of dialysate in a 3-stream proportioning hemodialysis machine according ... 2 07/16/2021 Fresenius Medical Care Holdings, Inc.
Z-2088-2021 - The Fresenius APD Luer-Lock Adapter, Catalog number 050-95018, is designed to connect a peritoneal dialysis bag equipped with a luer-lock connector to a Fresenius Automated Peritoneal Dialysis (APD) c... 2 07/16/2021 Fresenius Medical Care Holdings, Inc.
Z-2089-2021 - The MTS Set is a single-use, sterile (EO), non-pyrogenic, optional accessory that provides additional connections/disconnections when used with a stay"safe compatible cycler set during acute and chron... 2 07/16/2021 Fresenius Medical Care Holdings, Inc.
Z-2086-2021 - Citrasate Liquid Acid Concentrate and NaturaLyte Liquid Acid Concentrate are each intended to be used as one component in the preparation of dialysate in a 3-stream proportioning hemodialysis machine ... 2 07/16/2021 Fresenius Medical Care Holdings, Inc.
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