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.
Recall
- Recall Number
- Z-1622-2008
- Event Number
- 47753
- Firm
- Smiths Medical MD, Inc.
- FEI Number
- 2183502
- Product Code
- LZG
- Status
- Terminated
- Root Cause
- Component change control
- Initiated
- March 10, 2008
- Posted
- August 15, 2008
- Terminated
- January 13, 2011
- Address
- 1265 Grey Fox Rd, Saint Paul, MN, 55112-6929
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.
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.
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.
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.
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