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Fresenius Medical Care Holdings, Inc. dba Renal Solutions recalls 2008 MeDS Pump, Venofer(R) Pump Product Usage: The 2008 MeDs pump is an optional accessory for use with the Freseniu
Recalled September 4, 2013 · FDA recall Z-2082-2013 · Fresenius Medical Care Holdings, Inc.
Hazard
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 Bloodlines can lead to a situation where Venofer(R) delivery does not meet dosage accuracy requirements. This may lead to a slight over or under delivery of Venofer(R) that does not pose an acceptable risk to the patient. Please note that this recall · FDA Class II
Units
132
Sold at
USA Nationwide Distribution in the states of CA, MA, and NY.
Description
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 Bloodlines can lead to a situation where Venofer(R) delivery does not meet dosage accuracy requirements. This may lead to a slight over or under delivery of Venofer(R) that does not pose an acceptable risk to the patient. Please note that this recall
Product
2008 MeDS Pump, Venofer(R) Pump Product Usage: The 2008 MeDs pump is an optional accessory for use with the Fresenius 2008 Series Hemodialysis Machines and is intended to administer Venofer to treat iron deficiency anemia in patients with chronic kidney disease undergoing hemodialysis, where Venofer, in conjunction with hemodialysis, is prescribed by a physician.
Manufacturer(s)
Fresenius Medical Care Holdings, Inc. dba Renal Solutions
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →