Events

Recall of Device Recall NiproSet SLIMLINE Blood Tubing Set

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Nipro Medical Corporation.

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
    72701
  • Event Risk Class
    Class 2
  • Event Number
    Z-0624-2016
  • Event Initiated Date
    2015-03-30
  • Event Date Posted
    2016-01-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-02-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142001
  • 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
    Set, tubing, blood, with and without anti-regurgitation valve - Product Code FJK
  • Reason
    Blood foaming was found during evaluation of the product.
  • Action
    NIPRO contacted their consignees by email 9/25/2013 of the affected product. Customers were instructed to return product back to Nipro Medical Warehouse or discard at point of use. Please contact Director of QA/RA at Nipro Medical Corporation for any additional information or return correspondence to JessicaO@nipromed.com / 305.599.7174x249.

Device

Device Recall NiproSet SLIMLINE Blood Tubing Set
  • Model / Serial
    Lot #'s 13E02, 13E03, 13E06, 13E07, 13E08,13E09, 13E10, 13G03, 13G11, 13G15, 14G24, 13G30, and 13H06.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution to states of: TN and NJ.
  • Product Description
    NIPRO SET / SLIMLINE BLOOD TUBING SET for Hemodialysis with Transducer Protectors and Priming Set || A disposable bloodline intended to provide extracorporeal access to the patient's blood during Hemodialysis. Compatible for use with Fresenius 2008H, 2008K/K2 and 2008T dialysis machines.
  • Manufacturer
    Nipro Medical Corporation

Manufacturer

Nipro Medical Corporation
  • Manufacturer Address
    Nipro Medical Corporation, 3150 Nw 107th Ave, Miami FL 33172
  • Manufacturer Parent Company (2017)
    Nipro Corporation
  • Source
    USFDA