Events

Recall of Device Recall Curlin Infusion Administration Set

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

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
    61446
  • Event Risk Class
    Class 2
  • Event Number
    Z-1416-2012
  • Event Initiated Date
    2012-03-20
  • Event Date Posted
    2012-04-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-07-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108280
  • 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
    Pump, infusion - Product Code FRN
  • Reason
    Ambulatory administration sets used with the curlin ambulatory pumps including the 4000 cms ambulatory pump, 6000 cms ambulatory pump and the pain smart iod ambulatory pump may leak during use.
  • Action
    Moog Medical Device Group sent a Medical Device Recall Notification letter dated March 20, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to remove the affected product from their inventory, contact the distributor or Moog Customer Service at 1-800-970-2337, prompt #7, then return product to distributor or Moog. For additional questions regarding this recall call Moog's Customer Service Department at (800) 970-2337.

Device

Device Recall Curlin Infusion Administration Set
  • Model / Serial
    Product Number: 340-4168 Lot Numbers: CF1125112,,, CF1125111,,, CF1129206,,, CF1129207,,, CF1130013
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including AZ,,, CA,,, FL,,, GA,,, KS,,, IL,,, MA,,, MD,,, MI,,, OH,,, PA,,, TX,,, VA,,, WI,,, and the countries of Germany,,, Italy,,, Morocco,,, New Zealand,,, and the United Arab Emirates,,,
  • Product Description
    Non-Vented Bag Spike, Microbore tubing w/free-flow protection, slide clamp ASV || The Curlin Ambulatory Infusion Pump System with disposable PVC Administration Tubing Sets and user accessories, provide a means for the volumetric delivery of fluids used in Parenteral, Enteral, Epidural, Subcutaneous and Intravenous applications.
  • Manufacturer
    MOOG Medical Devices Group

Manufacturer

MOOG Medical Devices Group
  • Manufacturer Address
    MOOG Medical Devices Group, 4314 Zevex Park Ln, Salt Lake City UT 84123-7881
  • Manufacturer Parent Company (2017)
    Moog Inc
  • Source
    USFDA