Events

Recall of 3 PORT "OFF" MANIFOLD w/WASTE BAG, SYRINGE and DyePod

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
    63362
  • Event Risk Class
    Class 2
  • Event Number
    Z-0055-2013
  • Event Date Posted
    2012-10-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-02-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=113585
  • 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, diagnostic - Product Code DQO
  • Reason
    Icu medical, inc. has identified a potential comingling of components where a 60 drop micro drip chamber may have been included on a 20 drop macro drip set.
  • Action
    ICU Medical sent an "URGENT:MEDICAL DEVICE RECALL" letter dated September 28, 2012 to its customer. The letter identified the product, problem, and actions to be taken by the customer. The customer has been instructed to inspect their inventory for the specific lot numbers, examine for the presence of a metal cannula, and certify destruction of any affected devices. The customer letter included a Verification Form to be completed and returned. 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" for questions regarding this notice.

Device

3 PORT "OFF" MANIFOLD w/WASTE BAG, SYRINGE and DyePod
  • Model / Serial
    Part Number (Item #) AG8049-NS, Lot # 2528655.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution: Virginia only.
  • Product Description
    3 PORT "OFF" MANIFOLD w/WASTE BAG, SYRINGE and || DyePod¿, Part Number (Item #) AG8049-NS, Lot # 2528655. || K914299. || Waste system.
  • 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