2008 MeDS Pump — Class II medical device recall Z-2082-2013
Terminated recall by Fresenius Medical Care Holdings, Inc. dba Renal Solutions, reported 2013-09-04, distributed nationwide. Product is being recalled because the combination of the current 50 mg vial, the 2008 MeDS pump, and the 2008
| Recall number | Z-2082-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fresenius Medical Care Holdings, Inc. dba Renal Solutions, Warrendale, PA, United States |
| Recall initiated | 2013-04-01 |
| Classified | 2013-08-26 |
| Reported by FDA | 2013-09-04 |
| Terminated | 2015-03-02 |
| Distributed | Nationwide (US) |
| Quantity | 132 |
| Serial numbers | TM-000002, TM-000003, TM-000004, TM-000005, TM-000006, TM-000007, TM-000008, TM-000009, TM-000010, TM-000012, TM-000013, TM-000014, TM-000015, TM-000017, TM-000018, TM-000019, TM-000020, TM-000023, TM-000024, TM-000025, TM-000028, TM-000031, TM-000033, TM-000036, TM-000040 and 107 more |
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 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
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.