Events

Recall of Device Recall 8" (20 cm) Appx 0.43 ml, Smallbore Bifuse Ext Set w/2 NanoClave", 2

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

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
    67166
  • Event Risk Class
    Class 2
  • Event Number
    Z-0697-2014
  • Event Initiated Date
    2013-12-24
  • Event Date Posted
    2014-01-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-04-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124847
  • 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, administration, intravascular - Product Code FPA
  • Reason
    Icu medical is recalling certain lots of the nanoclave needlefree connector product line because of a small percentage of devices that may leak.
  • Action
    icumedical sent an Urgent Medical Device Recall letter dated December 24, 2013, to all affected customers. The letter informed the customers of the problems identified and the actions to be taken. Customers were instructed to return completed verification forms. Customers with questions were instructed to contact ICU Customer Service Monday through Friday between the hours of 8:30AM and 4:00PM Pacific Time: (866) 829-9025 and select option 8, or email: customerservice@icumed.com. ICU Medical reported an update on January 6, 2014, an expansion of the recall to additional lots. Updated recall letter was sent out to all customers on additional lots on January 6, 2014 via UPS with tracking. For questions regarding this recall call 949-366-2183.

Device

Device Recall 8" (20 cm) Appx 0.43 ml, Smallbore Bifuse Ext Set w/2 NanoClave", 2
  • Model / Serial
    Lot No. 2767376
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including UT, TX, GA, WI, VT, NH, AL, OH, TN, IL, CA, KY,HI, NC, and Internationally to CA, BE, IN, KW, and AU.
  • Product Description
    8" (20 cm) Appx 0.43 ml, Smallbore Bifuse Ext Set w/2 NanoClave", 2 || Clamps, Luer Lock, Part No. A1000, Item No. K7107-001 || The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.
  • Manufacturer
    ICU Medical, Inc.

Manufacturer

ICU Medical, Inc.
  • Manufacturer Address
    ICU Medical, Inc., 951 Calle Amanecer, San Clemente CA 92673-6212
  • Manufacturer Parent Company (2017)
    ICU Medical, Inc.
  • Source
    USFDA