Events

Recall of 2008 MeDS Pump, Venofer(R) Pump

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Fresenius Medical Care Holdings, Inc. dba Renal Solutions.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    65080
  • Event Risk Class
    Class 2
  • Event Number
    Z-2082-2013
  • Event Initiated Date
    2013-04-01
  • Event Date Posted
    2013-08-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-03-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117850
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Dialyzer, high permeability with or without sealed dialysate system - Product Code KDI
  • 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.
  • Action
    Renal Solutions sent an Urgent Notification letter dated April 1, 2013 via certified mail to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to cease further use of the device. The letter informed customers that a Fresenius Medical Care Technical Service/Customer Service representative will contact customers to arrange for removal of the device. For questions contact Fresenius Medical Care Customer Service at 800-227-2572.

Device

2008 MeDS Pump, Venofer(R) Pump
  • Model / Serial
    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.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    USA Nationwide Distribution in the states of CA, MA, and NY.
  • Product Description
    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.
  • Manufacturer
    Fresenius Medical Care Holdings, Inc. dba Renal Solutions

Manufacturer

Fresenius Medical Care Holdings, Inc. dba Renal Solutions
  • Manufacturer Address
    Fresenius Medical Care Holdings, Inc. dba Renal Solutions, 770 Commonwealth Dr Ste 101, Warrendale PA 15086-7521
  • Manufacturer Parent Company (2017)
    Fresenius SE & Co KGaA
  • Source
    USFDA