Reported Sep 4, 2013 · Terminated

2008 MeDS Pump, Venofer(R) Pump Product Usage: The 2008 MeDs pump is an optional accessory for use with the Fresenius…

Fresenius Medical Care Holdings, Inc. dba Renal Solutions

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Fresenius Medical Care Holdings, Inc. dba Renal Solutions · 770 Commonwealth Dr Ste 101 · Warrendale, PA · 15086-7521

Is this the product you have?

2008 MeDS Pump
Venofer(R) Pump Product UsageThe 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

Lot codes and dates: 132 of 132 codes
Serial numbers - TM-001065
TM-001283
TM-001284
TM-001325
TM-001411
TM-001426
TM-001465
TM-001476
TM-001529
TM-001967
TM-001968
TM-001975
TM-001985
TM-002015
TM-002016
TM-002017
TM-002018
TM-002021
TM-002022
TM-002095
TM-000015
TM-000028
TM-000031
TM-000041
TM-0048
TM-000050
TM-000051
TM-000053
TM-000055
TM-000059
TM-000064
TM-000065
TM-000068
TM-0069
TM-000213
TM-000215
TM-000218
TM-000219
TM-000070
TM-000072
TM-000074
TM-000075
TM-000078
TM-000081
TM-000082
TM-000083
TM-000085
TM-000086
TM-000087
TM-000088
TM-000089
TM-000092
TM-000040
TM-000077
TM-000098
TM-000101
TM-000102
TM-000103
TM-000104
TM-000105
Amount recalled: 132

Where it was sold

Nationwide
CA
MA
NY

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where it was distributed

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