Events

Recall of Device Recall Nipro Blood Tubing set with Priming Set and Transducer Protectors. Each device is packaged in a film

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
    79834
  • Event Risk Class
    Class 2
  • Event Number
    Z-1876-2018
  • Event Initiated Date
    2017-12-19
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=163665
  • 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
    There is a possibility of the heparin line is occluded.
  • Action
    Customers were notified on approximately December 19, 2017, via letter. Instructions included to place affected lots on hold and to advise Nipro if any affected product has been further distributed. If affected product has been further distributed, Nipro advised the customer to notify those customers and have the product returned immediately. Additionally Nipro requested that they complete and return the response form to arrange for product return. For further questions, please call (305) 599-7174.

Device

Device Recall Nipro Blood Tubing set with Priming Set and Transducer Protectors. Each device is ...
  • Model / Serial
    Model No. BL+A223D/V809D, Vendor Batch No. 17I06-9, 17I16-9, 17I18-9, 17J17-9, 17J19-9 , 17J20-9 , 17J21-9, 17I19-9, 17K07-9 , 17I01-9, 17J12-9, 17J16-9, 17I21-9, 17I25-9, 17I26-9, 17J09-9, 17J11-9, 17K15-9, 17K16-9.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution to the states of : GA, NY, TN, TX.
  • Product Description
    Nipro Blood Tubing set with Priming Set and Transducer Protectors. Each device is packaged in a film pouch with 24 lines per case. || The Nipro¿ Set - Blood Tubing Set with Transducer Protector and Priming Set are disposable bloodlines intended to provide extracorporeal access to the patient s blood during hemodialysis. The compatibility of available configurations is the responsibility of the physician in charge.
  • Manufacturer
    Nipro Medical Corporation

Manufacturer

Nipro Medical Corporation
  • Manufacturer Address
    Nipro Medical Corporation, 3150 NW 107th Ave, Doral FL 33172-2135
  • Manufacturer Parent Company (2017)
    Nipro Corporation
  • Source
    USFDA