Fresenius Medical Care Holdings, Inc.: Exposed to freezing temperatures due to refrigerated truck malfunctions

Agency Publication Date: July 16, 2021

Affected Products

Product: 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

Lot Number: 20HR08054 UDI: (01)00840861101115

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Product: 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 according to a physician s prescription. Both concentrates are formulated for use in 45X proportioning systems which proportion a nominal ratio of 1 : 1.72 : 42.28 (acid : bicarbonate : water) to generate dialysate. The dialysate is intended to be pumped through a dialyzer, creating an osmotic gradient acro

Lot Number/UDI: (1) 21ATGF013 (01)00884086110135 0FD3251-3B (2) 20SXGF010 (01)00840861101597 0FD3251-3B (3) 20SXGF013 (01)00840861101597

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Product: (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 setting GRANUFLO & NATURALYTE: Concentrate is formulated to be used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.

(1) Lot Number: B4MA27140 BAG GTIN CASE GTIN BIBAG 650 GRAMS 08-4078-BB 00840861101313 10840861101310 (2) Lot Number: B5MB24110 BAG GTIN CASE GTIN BIBAG 900 GRAMS 08-4080-BB 00840861101320 10840861101327

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Product: 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 than letting the effluent flow directly to a drain. The Drain Bag Set connects to the drain line of a cycler set to collect patient effluent by means of gravity and the pumping action of a Peritoneal Dialysis (PD) cycler. The Drain Bag Set connects to the drain line using a standard Luer lock connec

Lot Number: 20NR08163 UDI: (01)00840861102037

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Product: 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 according to a physician s prescription. Both concentrates are formulated for use in 45X proportioning systems which proportion a nominal ratio of 1 : 1.72 : 42.28 (acid : bicarbonate : water) to generate dialysate. The dialysate is intended to be pumped through a dialyzer, creating an osmotic gradi

Lot Number/UDI: (1)21BTAC004 UDI: (01)00840861101535 (2)21AGAC026 UDI: (01)00840861101696 (3)21BTAC008 UDI: (01)00840861101740

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Product: 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 to a physician s prescription. NaturaLyte Dry Bicarbonate Concentrate is formulated for use in 45X proportioning systems which proportion a nominal ratio of 1 : 1.72 : 42.28 (acid : bicarbonate : water) to generate dialysate. The dialysate is intended to be pumped through a dialyzer, creating an osm

Lot Number: 21ATBC004 UDI: (01)00840861101955

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Product: 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) cycler set that uses the Fresenius Safe-Lock¿ connector (e.g., Liberty¿ cycler, Newton IQO cycler).

Lot Number: 20LR08111 UDI: (01)00840861100811

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Product: 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 chronic PD treatment. The MTS Set utilizes the same PIN engagement technology used in Fresenius stay"safe Patient Connectors (K041792). The MTS Set consists of two (2) stay"safe PIN Connectors at the proximal end, tubing, and a Safe-Lock connector at the distal end. The MTS Set is attached to a cycler se

Lot Number: 20SR08069 UDI: (01)00840861100811 20PR08237 UDI: (01)00840861100811

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Product: 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 Use Fresenius Sterile Stay Safe¿ Cap is intended to be used for closure of the stay safe peritoneal dialysis connectology system

Lot Number: B1ZH191, B1ZI092

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Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 87998

Status: Resolved

Manufacturer: Fresenius Medical Care Holdings, Inc.

Manufactured In: United States

Units Affected: 9 products ((1) 20 cases (2) 30 cases; 10 cases; (1) 40 cases (2) 3 cases (3) 4 cases; 6 Cases; (1) 1 case (2) 4 cases (3) 5 cases; 120 Bags; 5 cases; 5 cases; 39 cases)

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Sources: FDA iRES · Raw API Response

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Affected Products

Product: 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

Lot Number: 20HR08054 UDI: (01)00840861101115

Lot Numbers:

Number

Lot Number/UDI: (1) 21ATGF013 (01)00884086110135 0FD3251-3B (2) 20SXGF010 (01)00840861101597 0FD3251-3B (3) 20SXGF013 (01)00840861101597

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Lot Numbers:

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Lot Number: 20NR08163 UDI: (01)00840861102037

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Number

Lot Number/UDI: (1)21BTAC004 UDI: (01)00840861101535 (2)21AGAC026 UDI: (01)00840861101696 (3)21BTAC008 UDI: (01)00840861101740

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Lot Number: 21ATBC004 UDI: (01)00840861101955

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Lot Number: 20LR08111 UDI: (01)00840861100811

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Lot Number: 20SR08069 UDI: (01)00840861100811 20PR08237 UDI: (01)00840861100811

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Lot Number: B1ZH191, B1ZI092

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Number

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 87998

Status: Resolved

Manufacturer: Fresenius Medical Care Holdings, Inc.

Manufactured In: United States

Units Affected: 9 products ((1) 20 cases (2) 30 cases; 10 cases; (1) 40 cases (2) 3 cases (3) 4 cases; 6 Cases; (1) 1 case (2) 4 cases (3) 5 cases; 120 Bags; 5 cases; 5 cases; 39 cases)