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Terminated

Deltec Cozmo Insulin Pump, Model 1800 Smiths Medical International Ltd WD24 4LG UK, Smiths Medical MD, Inc., St Paul, MN 55112. This Pump is similar to the currently distributed Deltec Cosmo Insulin Pump Model 1700 pump, 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. REF 21-1801-81, 21-1803-81, 21-1805-49/51/81, 21-1806-51/81, 21-1807-49

FDA Recall Z-1623-2008 · Posted 2008-08-15

Recalling FirmSmiths Medical MD, Inc.
Recall StatusTerminated
Product CodeLZG
Date Initiated2008-03-10
Date Terminated2011-01-13
Product Quantity1066

Reason for Recall

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.

Firm 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.

Root Cause

Component change control

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K062323DELTEC COZMO INSULIN INFUSION PUMP WITH COZMONITOR BLOOD GLUCOSE METER, MODELS 21-1815, 21-1816, 21-1817Smiths Medical MD, Inc. · 2006-11-01

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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