Events

Recall of Device Recall MOOG Curlin Infusion Administration Set

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Zevex Incorporated (dba Moog Medical 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
    78573
  • Event Risk Class
    Class 2
  • Event Number
    Z-0699-2018
  • Event Initiated Date
    2017-11-10
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=159788
  • 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
    Particulate found on the curlin spike.
  • Action
    The recalling firm began issuing letters via USPS certified mail with return receipt on 11/10/2017 and concluded on 11/13/2017. Updated letters dated 11/20/2017 were issued via certified mail to distributors and to medical facilities. The distributor letter emphasized their instructions to notify downstream accounts. The medical facility letter updated lot numbers. The letter described the issue, risk to health, and actions the customer was to take. A response form was enclosed to report whether the customer has inventory they are not returning, that they no longer have inventory of the product, or the amount of product being returned for replacement. The form was to be returned via FAX or email.

Device

Device Recall MOOG Curlin Infusion Administration Set
  • Model / Serial
    UDI 38148440000495, Lot/serial numbers: CF1518304, CF1521104, CF1524301, CF1523803, CF1528603, and CF1613101.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distribution was nationwide. There was government and military distribution. Foreign distribution was made to Canada, Saudi Arabia, Turkey, Croatia, United Arab Emirates, and Australia.
  • Product Description
    MOOG Curlin Infusion Administration Set, Ref 340-4134, Non-DEHP Microbore Tubing with Non-Vented Bag Spike and Y-Site with Check Valve, packaged 20/box, for use with the Moog Curlin Ambulatory Volumetric Infusion Pump, RX, Sterile. || Product Usage: || Administration set to be used with the Moog Curlin infusion Pump. The pump can be used for intravenous, intra-arterial, epidural, subcutaneous, or enteral infusions.
  • Manufacturer
    Zevex Incorporated (dba Moog Medical Medical Devices Group)

Manufacturer

Zevex Incorporated (dba Moog Medical Medical Devices Group)
  • Manufacturer Address
    Zevex Incorporated (dba Moog Medical Medical Devices Group), 4314 S Zevex Park Ln, Salt Lake City UT 84123-7881
  • Source
    USFDA