Events

Rappel de 2008 MeDS Pump, Venofer(R) Pump

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Fresenius Medical Care Holdings, Inc. dba Renal Solutions.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    65080
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2082-2013
  • Date de mise en oeuvre de l'événement
    2013-04-01
  • Date de publication de l'événement
    2013-08-26
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-03-02
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117850
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Dialyzer, high permeability with or without sealed dialysate system - Product Code KDI
  • Cause
    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
  • Modèle / numéro de série
    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.
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    USA Nationwide Distribution in the states of CA, MA, and NY.
  • Description du dispositif
    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
  • Adresse du fabricant
    Fresenius Medical Care Holdings, Inc. dba Renal Solutions, 770 Commonwealth Dr Ste 101, Warrendale PA 15086-7521
  • Société-mère du fabricant (2017)
    Fresenius SE & Co KGaA
  • Source
    USFDA