Events

Recall of Device Recall Model 2000 CMS/ Model 2000 Plus Ambulatory Infusion Pump

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

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
    48639
  • Event Risk Class
    Class 2
  • Event Number
    Z-1896-2008
  • Event Initiated Date
    2008-05-30
  • Event Date Posted
    2008-09-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-06-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=71773
  • 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
    Infusion Pump - Product Code FRN
  • Reason
    Over-delivery/free-flow involving curlin ambulatory peristaltic multi-therapy infusion pumps where the pumping chamber door (platen) had become deformed in a manner that permitted gravity flow.
  • Action
    On May 30, 2008, Curlin Medical began distribution of a "Voluntary Field Correction Advisory Notice" to all customers in the United States via USPS Registered Mail. The Notice informed customers of the problem and gave the customers (1) Guidelines on testing pump volumetric accuracy, (2) Updated user manuals to elevate the "caution" statement related to dropped pumps to a "warning" statement, and (3) A warning label to be located on the pump: "Warning: Impact may cause damage. If dropped, pump must be checked for accuracy prior to use". A toll free number (888-287-5999) was given for customers experiencing issues that require immediate assistance.

Device

Device Recall Model 2000 CMS/ Model 2000 Plus Ambulatory Infusion Pump
  • Model / Serial
    Serial Numbers for all affected units: 100074 to 210458
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution --- including USA and countries of Australia, Croatia, Germany, Italy, New Zealand, and South Africa.
  • Product Description
    Model 2000 CMS/ Model 2000 Plus Ambulatory Infusion Pump, Model Number: 340-1001
  • Manufacturer
    Curlin Medical Llc

Manufacturer

Curlin Medical Llc
  • Manufacturer Address
    Curlin Medical Llc, 15751 Graham St, Huntingtn Bch CA 92649-1630
  • Manufacturer Parent Company (2017)
    Moog Inc
  • Source
    USFDA