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Fresenius Medical Care Holdings, Inc.

140 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Optiflux F180NR High Flux Dialyzers; Product Number: 0500318N. Single Use acute or chronic recall (Z-1101-2014)Fresenius Medical Care Holdings, Inc.2014-02-26
Optiflux F200NRe High Flux Dialyzers; Product Number: 0500320E. Single Use acute or chroni recall (Z-1102-2014)Fresenius Medical Care Holdings, Inc.2014-02-26
Optiflux F200NR High Flux Dialyzers; Product Number: 0500320N. Single Use acute or chronic recall (Z-1103-2014)Fresenius Medical Care Holdings, Inc.2014-02-26
Optiflux F200A High Flux Dialyzers; Product Number: 0500320A. Single Use acute or chronic recall (Z-1104-2014)Fresenius Medical Care Holdings, Inc.2014-02-26
Optiflux B200 Flux Dialyzers; Product Number: 0500325E. Single Use acute or chronic hemana recall (Z-1105-2014)Fresenius Medical Care Holdings, Inc.2014-02-26
Optiflux F18Nre Flux Dialyzers; Product Number: 0500308E. Single Use acute or chronic hema recall (Z-1106-2014)Fresenius Medical Care Holdings, Inc.2014-02-26
Fresenius Bicarbonate Jug Adapter to the 2008 Series Hemodialysis machine Part Number: 650 recall (Z-0920-2014)Fresenius Medical Care Holdings, Inc.2014-02-03
Fresenius 2008 Series Hemodialysis Machines: Models: 2008H, 2008K, 2008K2, 2008k@Home, 200 recall (Z-0629-2014)Fresenius Medical Care Holdings, Inc.2014-01-06
2008K@ Home Blood lines Combiset True Flow Series for Hemodialysis use Catalog Number: 03- recall (Z-0184-2014)Fresenius Medical Care Holdings, Inc.2013-11-08
Combiset Blood Line with BVM for Hemodialysis use Catalog Number: 03-2965-9. Intended for recall (Z-0185-2014)Fresenius Medical Care Holdings, Inc.2013-11-08
Combiset Blood Line Hemodialysis use Catalog Number: 03-2622-3. Intended for use as the ex recall (Z-0186-2014)Fresenius Medical Care Holdings, Inc.2013-11-08
Fresenius Liberty Cycler Part Number: RTLR180111 Product Usage: The Liberty cycler is a po recall (Z-0148-2014)Fresenius Medical Care Holdings, Inc.2013-11-05
Fresenius Service Replacement 0-Ring. Used in as a service part in 4 sub-assemblies manufa recall (Z-1693-2013)Fresenius Medical Care Holdings, Inc.2013-07-11
Fresenius Liberty Cycler Set Single Conn./Ext DL Product Number: 050-87216 Automated Perit recall (Z-1674-2013)Fresenius Medical Care Holdings, Inc.2013-07-10
Fresenius Liberty Cycler Set Single Conn. Ext. DL. Part Number: 050-87216. Acute and chron recall (Z-0799-2013)Fresenius Medical Care Holdings, Inc.2013-02-11
Fresenius GranuFlo Dry Acid Concentrate For Bicarbonate Dialysis 2.0 K 2.5 Ca 1 Mg 16.5 GA recall (Z-0676-2013)Fresenius Medical Care Holdings, Inc.2013-01-17
Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 2.0K 2.0 Ca 1M recall (Z-0677-2013)Fresenius Medical Care Holdings, Inc.2013-01-17
Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 3.0K 2.5 Ca 1M recall (Z-0678-2013)Fresenius Medical Care Holdings, Inc.2013-01-17
Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 2.0K 2.25 Ca 1 recall (Z-0679-2013)Fresenius Medical Care Holdings, Inc.2013-01-17
Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 1.0K 2.0 Ca 1M recall (Z-0680-2013)Fresenius Medical Care Holdings, Inc.2013-01-17
Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 2.0K 2,5 Ca 0. recall (Z-0681-2013)Fresenius Medical Care Holdings, Inc.2013-01-17
Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 2.0K 2,5 Ca 0. recall (Z-0682-2013)Fresenius Medical Care Holdings, Inc.2013-01-17
Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 3.0K 2,0 Ca 1. recall (Z-0683-2013)Fresenius Medical Care Holdings, Inc.2013-01-17
Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 3.0K 2,5 Ca 0. recall (Z-0684-2013)Fresenius Medical Care Holdings, Inc.2013-01-17
Fresenius NaturaLyte Liquid Acid Concentrate Product Codes: 08-0231-4, 08-1001-0, 08-1201- recall (Z-1826-2012)Fresenius Medical Care Holdings, Inc.2012-06-25
Fresenius GranuFlo (powder) Acid Concentrate Product Codes: OFD1201-3B, OFD1251-3B, OFD212 recall (Z-1827-2012)Fresenius Medical Care Holdings, Inc.2012-06-25
Fresenius Medical Naturalyte Acid Concentrate for bicarbonate Dialysis 45x , 55 gallons (2 recall (Z-1612-2012)Fresenius Medical Care Holdings, Inc.2012-05-15
Fresenius Liberty Cycler Software, User Manuals, and Handi-Guides for acute and chronic pe recall (Z-1448-2012)Fresenius Medical Care Holdings, Inc.2012-04-24
Fresenius Optiflux F160NRe Hemodialyzer Catalog number: 0500316E Intended for patients wit recall (Z-1339-2012)Fresenius Medical Care Holdings, Inc.2012-03-30
Fresenius Optiflux F250NRe Hemodialyzer, , intended for single use in acute and chronic he recall (Z-0825-2012)Fresenius Medical Care Holdings, Inc.2012-01-20
CombiSet True Flow" 2008K@home Bloodlines Fresenius Medical Care. Used for transferring bl recall (Z-3269-2011)Fresenius Medical Care Holdings, Inc.2011-09-20
Fresenius 2008K@home The Fresenius 2008K@home is indicated for acute and chronic dialysis recall (Z-3083-2011)Fresenius Medical Care Holdings, Inc.2011-08-29
Naturalyte@ Sodium Bicarbonate Liquid Concentrate, Dialysate Concentrate for Hemodialysis recall (Z-2551-2011)Fresenius Medical Care Holdings, Inc.2011-06-10
Fresenius Optiflux F250NRe Hemodialyzer, Single Use, Catalog Number: 0500325E, Advanced Fr recall (Z-1622-2011)Fresenius Medical Care Holdings, Inc.2011-03-22
Fresenius 2008T Hemodialysis Machine Part Number 190573, 2008T Hemodialysis System, OLCIDI recall (Z-1526-2011)Fresenius Medical Care Holdings, Inc.2011-03-04
Fresenius Medical CombiSet BVM Hemodialysis Blood Tubing Set P/N: 03-2695-9 recall (Z-0843-2011)Fresenius Medical Care Holdings, Inc.2011-01-10
Fresenius Medical CombiSet BVM Hemodialysis Blood Tubing Set P/N: 03-2795-7 recall (Z-0844-2011)Fresenius Medical Care Holdings, Inc.2011-01-10
LIBERTY Automated Peritoneal Dialysis System Line Cycler Set with stay safe connectors (Du recall (Z-0103-2011)Fresenius Medical Care Holdings, Inc.2010-10-20
LIBERTY Automated Peritoneal Dialysis System Line Cycler Set with stay safe connectors (Si recall (Z-0104-2011)Fresenius Medical Care Holdings, Inc.2010-10-20
LIBERTY Automated Peritoneal Dialysis System lntegrated Cycler Set with single stay safe p recall (Z-0105-2011)Fresenius Medical Care Holdings, Inc.2010-10-20
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