Recall archive
61 recalls · page 3 of 3
Reported Jun 18, 2014
NaturaLyte¿ Liquid Bicarbonate Concentrate, 6.4 liter bottle to be used with a hemodialysis unit; Part Number:…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Fresenius Medical Care Holdings, Inc.
Matched: Brand — Container cap may contain foreign material- 0.60% - 0.80% Manganese
FDA (openFDA device enforcement)
Reported May 28, 2014
Naturalyte Liquid Bicarbonate Concentrate, 6.4 Liter Bottle Part Number: 08-4000-LB The concentrate is formulated to be…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Fresenius Medical Care Holdings, Inc.
Matched: Brand — Naturalyte Liquid Bicarbonate maybe contaminated
1 more product in this recall
FDA (openFDA device enforcement)
Reported May 21, 2014
Fresenius 2008T Hemodialysis Machine with Revision K Actuator Test Boards and also sold as replacement parts for use…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Fresenius Medical Care Holdings, Inc.
Matched: Brand · Product · Product details — 2008-Series Hemodialysis Machines with Revision K Actuator Test Boards may fail to detect a disconnected Ultrafiltration (UF) Pump
1 more product in this recall
FDA (openFDA device enforcement)
Reported Mar 5, 2014
Optiflux F160NRe High Flux Dialyzers; Product Number: 0500316E. Single Use acute or chronic hemanalysis treatment.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Fresenius Medical Care Holdings, Inc.
Matched: Brand — Dialysate Port Leak During Priming of the Dialyzers
8 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 12, 2014
Fresenius Bicarbonate Jug Adapter to the 2008 Series Hemodialysis machine Part Number: 650103. The adapter is a socket…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Fresenius Medical Care Holdings, Inc.
Matched: Brand · Product · Product details — Bicarbonate Jug Adapter distributed prior to 510(k) approval
FDA (openFDA device enforcement)
Reported Jan 15, 2014
Fresenius 2008 Series Hemodialysis Machines: Models: 2008H, 2008K, 2008K2, 2008k@Home, 2008T The 2008H Hemodialysis…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Fresenius Medical Care Holdings, Inc.
Matched: Brand · Product · Product details — 2008 Series Hemodialysis Machines complaints of saline bags inappropriately filling during recirculation and setup
FDA (openFDA device enforcement)
Reported Nov 20, 2013
2008K@ Home Blood lines Combiset True Flow Series for Hemodialysis use Catalog Number: 03-2962-3. Intended for use as…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Fresenius Medical Care Holdings, Inc.
Matched: Brand — Updated Instructions for Use: Bloodline connections not tightened per instructions in the operator's manual may disconnect and lead to blood loss
2 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 13, 2013
Fresenius Liberty¿ Cycler Part Number: RTLR180111 Product Usage: The Liberty cycler is a portable device designed to…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Fresenius Medical Care Holdings, Inc.
Matched: Brand · Product · Product details — Fluid leaking may be observed inside the pump compartment of the Liberty Cycler and may result in dialysate becoming contaminated, potentially…
FDA (openFDA device enforcement)
Reported Sep 4, 2013
2008 MeDS Pump, Venofer(R) Pump Product Usage: The 2008 MeDs pump is an optional accessory for use with the Fresenius…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Fresenius Medical Care Holdings, Inc. dba Renal Solutions
Matched: Brand · Product · Product details — Product is being recalled because the combination of the current 50 mg vial, the 2008 MeDS pump, and the 2008 MeDS pump tubing Set for CombiSet…
FDA (openFDA device enforcement)
Reported Jul 17, 2013
Fresenius Liberty Cycler Set Single Conn./Ext DL Product Number: 050-87216 Automated Peritoneal Dialysis System with…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Fresenius Medical Care Holdings, Inc.
Matched: Brand · Product · Product details — Cassette may leak during set up or during peritoneal dialysis treatment
1 more product in this recall
FDA (openFDA device enforcement)
Reported Feb 20, 2013
Fresenius Liberty Cycler Set Single Conn. Ext. DL. Part Number: 050-87216. Acute and chronic peritoneal dialysis.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Fresenius Medical Care Holdings, Inc.
Matched: Brand · Product · Product details — There is a small risk of a leak in Cycler Sets and if the Cycler Set is punctured, the dialysate may become contaminated potentially resulting in…
FDA (openFDA device enforcement)
Reported Jan 23, 2013
Fresenius GranuFlo Dry Acid Concentrate For Bicarbonate Dialysis 2.0 K 2.5 Ca 1 Mg 16.5 GAL Catalog Number: OFD2251-3B…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Fresenius Medical Care Holdings, Inc.
Matched: Brand · Product · Product details — GranuFlo Dry Acid Concentrate may show discoloration
8 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 4, 2012
Fresenius NaturaLyte Liquid Acid Concentrate Product Codes: 08-0231-4, 08-1001-0, 08-1201-8, 08-1231-3, 08-1251-1,…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Fresenius Medical Care Holdings, Inc.
Matched: Brand · Product · Product details — Risk of Alkalosis with acetate containing dialysis acid concentrates
1 more product in this recall
FDA (openFDA device enforcement)
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