Events

Recall of Curlin Ambulatory 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
    63359
  • Event Risk Class
    Class 2
  • Event Number
    Z-0072-2013
  • Event Date Posted
    2012-10-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-04-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=113568
  • 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
    This recall is the same issue for the fda processed recall initiated by moog medical devices on 1/25/11 which was related to customers reporting unclearable air-in-line alarm with specific lot numbers of curlin administration sets used with curlin ambulatory infusion pumps. the lots associated with this recall were inadvertently omitted from the original recall which has since been terminated by.
  • Action
    MOOG sent a Medical Device Recall Notification letter dated September 26, 2012, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to remove product from their inventory and return to the firm. Customers were also instructed to contact their distributor to arrange for replacement product. For questions customers were instructed to call 1-800-970-2337, prompt #7. For questions regarding this recall call 801-264-1001.

Device

Curlin Ambulatory Infusion Administration Set
  • Model / Serial
    Product Code/Lot Number: 340-4166/CF1022906; 340-4128-V/CRF10082001; 340-4165/CF1022905.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including California
  • Product Description
    ***This recall is being conducted due to an incomplete recall for RES 57829*** Curlin Infusion Administration Set, REF 340-4165, Sterile EO, || 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