FDA Device recall Z-2082-2013
2008 MeDS Pump, Venofer(R) Pump Product Usage: The 2008 MeDs pump is an optional accessory for use with the Fresenius 2008 Series Hemodialy…
- FDA Device
- Class II
- terminated
- Published 2013-09-04
On 2013-09-04 the FDA classified a Class II recall of 2008 MeDS Pump, Venofer(R) Pump Product Usage: The 2008 MeDs pump is an optional accessory for use with the Fresenius 2008 Series Hemodialy… by Fresenius Medical Care Holdings, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2082-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-04-01 |
| Published | 2013-09-04 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Fresenius Medical Care Holdings |
| Distribution | US |
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
Identifiers
| code_info | Serial numbers - TM-001065, TM-001283, TM-001284, TM-001325, TM-001411, TM-001426, TM-001465, TM-001476, TM-001529, TM-…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, TM-000106, TM-000107, TM-000108, TM-000109, TM-000112, TM-000113, TM-000114, TM-000115, TM-000116, TM-000122, TM-000123, TM-000124, TM-000125, TM-000126, TM-000128, TM-000145, 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-000017, TM-00001 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2082-2013%22
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