Events

Recall of Device Recall Deltec Cozmo Insulin Pump, Model 1700

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
    47753
  • Event Risk Class
    Class 2
  • Event Number
    Z-1622-2008
  • Event Initiated Date
    2008-03-10
  • Event Date Posted
    2008-08-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-01-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=70068
  • 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
    Insulin pump - Product Code LZG
  • Reason
    Smith medical discovered an issue with a motor component in specific serial numbers of the deltec cozmo ¿insulin pump, model numbers 1700 and 1800. this issue affects how the motor operates and may cause an over-delivery of insulin which could result in injury to the user.
  • Action
    Consignees were mailed an Urgent Medical Device Recall letter dated March 10, 2008. The Urgent letter addressed to "Distributors, Clinicans, Patients and Other Customers" contains Description of the Problem, Results of Investigation, and Advise on Action to be taken by the User. The patient users will be required to return a Recall Confrirmation Form. The USA distributors, USA prescribing physicians and the USA managed Care Accounts (Insurance Companies) will be mailed also a cover letter.

Device

Device Recall Deltec Cozmo Insulin Pump, Model 1700
  • Model / Serial
    USA:  A08931 A37582 A13919 A39717 A43779 A45238 A31455 A38022 A21231 A14506 A40945 A19565 A26902 A31456 A19183 A11164 A43688 A54693 A22987 A34082 A35045 A31734 A16731 A17680 A20964 A12734 A24282 A26705 A35021 A23011 A34093 A39305 A21668 A30450 A16812 A23847 A39749 A22562 A18159 A38668 A23865 A19831 A14238 A42892 A15124 A27546 A29491 A18301 A24937 A16705 A11642 A41116 A23918 A40202 A26898 A18536 A21528 A24912 A23885 A45265 A19655 A22949 A20090 A14889 A31446 A46481 A23843 A48103 A44743 A24915 A22512 A32363 A21651 A30518 A18807 A20095 A13355 A35483 A24920 A29444 A35971 A12348 A34381 A36301 A30298 A30294 A45962 A23118 A16306 A29579 A40122 A44079 A23057 A14766 A59064 A47805 A42830 A23713 A38977 A18625 A27345 A13259 A32088 A21117 A44520 A35605 A30301 A47556 A39474 A14930 A25210 A35185 A38857 A34922 A27575 A21109 A32117 A13116 A33028 A43376 A17517 A21397 A40084 A23249 A17541 A46130 A21168 A22859 A25431 A40360 A24036 A31866 A34386 A39033 A23372 A45821 A28832 A39169 A42688 A27708 A25557 A14218 A25441 A24062 A35773 A36049 A25957 A36902 A39166 A28844 A25588 A18307 A40670 A26240 A16055 A30771 A43865 A27355 A57681 A35005 A41347 A23612 A25584 A17427 A31296 A22226 A14179 A39931 A41047 A14168 A39952 A25586 A25401   Int. OUSA: A62390 - A62410,   A64852 A64848 A64849 A64850 A64851 A13373 A43584 A31922 A43203 A20328 A22944 A23913 A25531 A27179 A34570 A39759 A10598 A14839 A24356 A37652 A43403 A23308 A31973 A13059 A15689 A20902 A46920 A29579 A40046 A40126 A42227 A17473 A33716 A23607 A27747 A64876 A64877 A64878 A64879 A64880 A64881 A64882 A64883 A64884 A64885 A64843 A64844 A64845 A64846 A64847 A64886 A64887 A64888 A64889 A64890 A64891 A64892 A64893 A64894 A64895 A64896 A64897 A64898 A64899 A64900 A64901 A64902 A64903 A64904 A64905 A64853 A64854 A64855 A64856 A64857 A64858 A64859 A64860 A64861 A64862 A64863 A64864 A64865 A64866 A64867 A64868 A64869 A64870 A64871 A64872 A64873 A64874 A64875 A23694 A62389 A62411 A62412 A62413 A62414 A62415 A62416 A62417 A62418 A62419 A62420 A62421 A62422 A62423 A62424 A62425 A62426 A62427 A62428 A62429 A62430 A62431 A62432 A62433 A62434 A62435 A62436 A62437 A62438 A62439 A62440 A62441 A62442 A64283 A64284 A64285 A64286 A64287 A37787 A64314 A64315 A64316 A64317 A64318 A64319 A64320 A64321 A64322 A64323 A64294 A64295 A64296 A64297 A64298 A64299 A64300 A64301 A64302 A64303 A64304 A64305 A64306 A64307 A64308 A64309 A64310 A64311 A64312 A64313 A64288 A64289 A64290 A64291 A64292 A64293 A28988 A44353 A29785 A42587 A27355 A22226  OUSA GERMANY A15333 A22296 A26590 A39620 A36148 A12916 A15802 A37829 A15783 A31614 A26588 A52036 A25358 A56553 A43596 A35741 A26279 A56671 A39281 A56678 A26437 A26508 A20796 A54523 A11423 A21748 A26404 A40423 A31601 A53074 A54437 A11768 A26460 A24169 A28369 A17974 A23650 A24394 A22742 A20848 A40466 A39649 A46748  AUSTRALIA A58721 A36572 A16409 A47779 A34280 A48715 A48800 A35900 A36880 A27391 A22826 A41379 A39273 A40077 A44953 A19952 A44360 A27706 A26090 A43476 A48470 A46076 A34462 and A57692.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Class II Recall - Worldwide Distribution --- USA including states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME. RO, MN, MO, MS, ME, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, and countries of Greece, Netherland, Sweden, France, Germany, Turkey, China, Great Britain, Israel, Italy, Kuwait, New Zealand, Australia.
  • Product Description
    Deltec Cozmo¿ Insulin Pump, Model 1700, Smiths Medical International Ltd WD24 4LG UK, Smiths Medical MD, Inc., St Paul, MN 55112. This is a syringe infusion pump intended for Continuous Subcutaneous Insulin Infusion for the control of diabetes.
  • 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