Recall Z-2082-2013— Fresenius Medical Care Holdings, Inc. dba Renal Solutions

Name: FDA recall Z-2082-2013
Creator: U.S. Food and Drug Administration
Published: 2013-04-01

Class II · Terminated

Class II FDA medical device recall by Fresenius Medical Care Holdings, Inc. dba Renal Solutions, initiated 2013-04-01, terminated 2015-03-02. It names one FDA 510(k) clearance: K121497. 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.. Reason: 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.

Recalling firm: Fresenius Medical Care Holdings, Inc. dba Renal Solutions
Classification: Class II
Status: Terminated
Initiated: 2013-04-01
Terminated: 2015-03-02
Firm location: Warrendale, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K121497 — VENOFER PUMPRenal Solutions, Inc.·cleared 2012-08-17

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.