Fresenius 2008 MeDS Pump Recalled for Venofer Dosage Accuracy Issues
Fresenius Medical Care is recalling 132 MeDS pumps used to administer Venofer during hemodialysis because the device may not meet dosage accuracy requirements.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text explicitly states that the dosage inaccuracy does not pose an acceptable risk to the patient, indicating a low-risk contamination or minor labeling/functional error rather than a significant injury risk.
Plain-English summary
Fresenius Medical Care Holdings, Inc. dba Renal Solutions is recalling 132 units of the 2008 MeDS Pump, an optional accessory for the Fresenius 2008 Series Hemodialysis Machines. The pump is intended to administer Venofer to treat iron deficiency anemia in patients with chronic kidney disease undergoing hemodialysis. The affected units were distributed nationwide in California, Massachusetts, and New York.
The recall was initiated because the combination of the 50 mg Venofer vial, the 2008 MeDS pump, and the 2008 MeDS pump tubing Set for CombiSet Bloodlines can lead to a situation where Venofer delivery does not meet dosage accuracy requirements. This may result in a slight over or under delivery of the medication, which the manufacturer states does not pose an acceptable risk to the patient.
Healthcare facilities and patients should stop using the affected pumps and contact Fresenius Medical Care for further instructions. The recall is classified as Class II by the FDA, indicating a reasonable probability that use of the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- 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 hem
- Hazard
- Affected units
- 132
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
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