Events

Recall of Device Recall CADD1 5100 AMBULATORY INFUSION PUMP

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Smiths Medical MD, 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
    50829
  • Event Risk Class
    Class 2
  • Event Number
    Z-0987-2009
  • Event Initiated Date
    2008-12-09
  • Event Date Posted
    2009-04-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-06-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=77443
  • 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 FPA
  • Reason
    Smiths medical noticed an increased trend in leakage associated with 100 ml cadd medication cassette reservoirs reorder number 21-7002-24 lot numbers 213x18 and 214x18. if a leak occurs in a cadd medication cassette reservoir, it may allow spillage of medication, contamination of the fluid path, and/or air to enter the reservoir. smiths medical has not received any report of patient injuries due.
  • Action
    An "Urgent Medical Device Recall" letter was sent via electronic mail to consignees on December 8, 2008. The letter was addressed to Distributors, Clinicians and other Customers. The letter described the problem and affected product and listed the "Advise on Action to be Taken by the User". Smiths Medical MD, Inc. requested the user to complete and return the "Urgent Medical Device Recall Confirmation Fax Return Form" and fax to the firm at 1-651-628-7485 or e-mail to info.md@smiths-medical.com (in US) or international.customer.service@smiths-medical.com (outside US). Direct questions to the Smiths Medical MD, Inc. Customer Service Department at 1-800-426-2448, Option 1.

Device

Device Recall CADD1 5100 AMBULATORY INFUSION PUMP
  • Model / Serial
    Lot Numbers 213X18 and 214X18.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution USA (state of PA) and countries of El Salvador, Australia, France, Finland, Sweden, and Germany.
  • Product Description
    CADD Medication Cassette Reservoir 100 ml with Clamp and Female Leur, Nonvented stopper included REF 21-7002-24, Sterile EO. || CADD Medication Cassette Reservoirs are intended for use with the CADD Ambulatory Infusion Pumps used for delivering drug therapy and anesthesia to patients. The pumps can be used by home care patients and in a healthcare facility.
  • Manufacturer
    Smiths Medical MD, Inc.

Manufacturer

Smiths Medical MD, Inc.
  • Manufacturer Address
    Smiths Medical MD, Inc., 1265 Grey Fox Rd, Saint Paul MN 55112-6929
  • Source
    USFDA