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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 65080

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
April 01, 2013
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Fresenius Medical Care Holdings, Inc. dba Renal Solutions

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-2082-2013
Recall number
Z-2082-2013
Initiated
April 01, 2013
Classification
Class II
Status
Terminated
Quantity
132

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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

Code information

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-000018, TM-000019, TM-000020, TM-000023, TM-000024, TM-000025, TM-000033, TM-000036, TM-A595, TM-A610, TM-A627, TM-000220, TM-000227, TM-007364, TM-007371, TM-006848, TM-006860, TM-006875, TM-006879, TM-006880, TM-006881, TM-006882, TM-006883, TM-006884, TM-006885, TM-006886, TM-006887, TM-006890, TM-006891, TM-006892, TM-006893, TM-006897, TM-006898, TM-006911, TM-006912, TM-006913, TM-006914, TM-006915, TM-006916, TM-006917, TM-006918, TM-006919, and TM-006920.

Distribution pattern

USA Nationwide Distribution in the states of CA, MA, and NY.

Field note

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