Events

Recall of Device Recall Nipro

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
    65274
  • Event Risk Class
    Class 2
  • Event Number
    Z-1834-2014
  • Event Initiated Date
    2013-05-04
  • Event Date Posted
    2014-06-19
  • 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=118426
  • 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
    Catheter,intravascular,therapeutic,short-term less than - Product Code FOZ
  • Reason
    There is a possibility of a crack in the cp luer connector. the position of the crack is at the connection site of the cp luer connector and the tubing. the crack could cause or contribute to leakage of fluids.
  • Action
    Nipro sent a Recall Notification letter dated April 4, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. This recall does extend to the customer level. Please notify all customers of the recall and collect all affected product that is in their possession. When all products have been received from your customers call tags and RMAs will be issued in order for you to return all products to Nipro Medical warehouse in Memphis TN. You will then be reimbursed for all products received. Please place all products you have in stock on hold. Use the attached faxback to respond to this notification, with product codes, lots and quantities you have in all of your distribution facilities. One form should be completed for each distribution location. Return forms as soon as possible to Nipro Medical, fax: 305.592.4621. Any questions or concerns can be addressed by phone at 305.599.7174 ext. 249.

Device

Device Recall Nipro
  • Model / Serial
    Product Code: PR+25G19, Lots #s 12H31H and 12I14H; Product Code: SPR+21G19, Lots #s 12I24 and 12J11; Product Code: PR-25G19, Lot # 12H27H; and PR-23G19, Lot # 12I12H.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA and the countries of Canada, Bolivia, Chile, Uruguay, Belize, Dominica, Honduras, Jamaica, Paraguay and Venezuela.
  • Product Description
    NIPRO Safe Touch Safety Scalp Vein Set
  • 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