Events

Recall of Intravascular Administration Set

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
    71028
  • Event Risk Class
    Class 2
  • Event Number
    Z-1589-2015
  • Event Initiated Date
    2015-04-20
  • Event Date Posted
    2015-05-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-11-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=135870
  • 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
    Stopcock, i.V. Set - Product Code FMG
  • Reason
    Icu medical is recalling microclave t-connectors because they have potential connection separation issues that could lead to leakage.
  • Action
    An Urgent Medical Device Recall letter dated 4/17/15 will be sent to customers on 4/20/15 to inform them that ICU Medical Inc. has identified a potential connection separation issue in a small number of isolated Intravenous Administration Transfer Sets. While the separation may be visually detected, if used, this failure mode could lead to leakage. The letter informs the customers of the problems identified and the actions to be taken. Customers are instructed to return completed recall response form to ICU Medical by Fax at (801) 264-1755 or email to recall@icumed.com. Customers with questions or require assistance relating to the recall are instructed to contact ICU Customer Service Monday through Friday between the hours of 8:30 AM and 4:00 PM Pacific time: 866-829-9025 and select option 8, or e-mail the following address: customerservice@icumed.com.

Device

Intravascular Administration Set
  • Model / Serial
    Lot No. 3002665 3004236 2995225
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide in US: SC, NC, MN, CT, KY, MD, FL, VA, TN
  • Product Description
    107" (272 cm) Ext Set w/2 Check Valves, MicroClave T-Connector, Clamp, Rotating Luer, Non-DEHP Tubing, Item No. B33041 || Product Usage: || IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile.
  • 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