Events

Recall of Device Recall Insulin 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
    47423
  • Event Risk Class
    Class 2
  • Event Number
    Z-1590-2008
  • Event Initiated Date
    2008-02-22
  • Event Date Posted
    2008-09-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-01-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=69478
  • 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 LZG
  • Reason
    Smith medical has received reports of deltec cozmo¿¿ insulin pumps powering down without an alarm. investigation concluded that if the battery cap is not fully tightened, the pump may power down and a brief "chirp" will sound. this may occur if the user has not sufficiently tightened the battery cap or if the battery cap is damaged. if a patient is asleep or does not regularly check their blood g.
  • Action
    Consignees and the USA demonstration pump physicians were mailed an "Urgent Medical Device Correction" letter on 2/22/08. The letter stated Details on Affected devices, Description of the problem, Advice on action to be taken by the user, Additional Information and New Warning. These consignees will be required to return the Correction Confirmation Form. The 17 countries with international mailing addresses were sent the Urgent Medical Device Correction letter (Urgent Field Safety Notice) via the Smiths Medical International Regulatory department based in Watford UK. The Smiths Medical Distributors and Affiliates will be required to mail the Safety Notice to their direct users. The USA distributors were mailed the Urgent Medical Device correction letter with a cover letter. These consignees will be required to add the letter to in-house inventory. The USA prescribing physician and the the USA Managed Care Accounts (Insurance Companies) were mailed the Urgent Medical Device Correction letter with a cover letter. These consignees will not be required to respond and no follow-up will be done by Smiths Medical. Contact Mike Herbert at 651-628-7049 if you have any questions or did not receive the recall information from the firm.

Device

Device Recall Insulin Infusion Pump
  • Model / Serial
    all serial numbers
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution --- USA including states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, and countries of AU, CA, CL, CN, DE, EG, FR, GB, GR, IL, KW, MX, NL, NZ, ON, PL, SA, SE, TR, UK.
  • Product Description
    Deltec Cozmo¿¿ Insulin Pump, model 21-1800. || This is similar to the currently distributed Deltec Cozmo¿¿ Insulin Pump Model 1700, with the exception of updated software that enhanced certain features and added a food data base to allow users to better manage dietary requirements in conjunction with the use of their insulin pump. || Reorder Numbers: || 21-1801-81 || 21-1803-81 || 21-1804-81 || 21-1805-49/51/81 || 21-1806-49/51/81 || 21-1807-49/51/81 || 21-1815-01/50 || 21-1816-01/50 || 21-1817-01/50
  • 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