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U.S. Department of Health and Human Services

Class 2 Device Recall DELTEC COZMO INSULIN INFUSION PUMP WITH COZMONITOR BLOOD GLUCOSE METER, MODELS 211815, 211816, 21

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  Class 2 Device Recall DELTEC COZMO INSULIN INFUSION PUMP WITH COZMONITOR BLOOD GLUCOSE METER, MODELS 211815, 211816, 21 see related information
Date Initiated by Firm November 20, 2008
Date Posted April 16, 2009
Recall Status1 Terminated 3 on June 05, 2012
Recall Number Z-0989-2009
Recall Event ID 50872
510(K)Number K062323  
Product Classification Pump, infusion, insulin - Product Code LZG
Product Deltec Cozmo¿ Insulin Pump, Model 1700 containing 1800 software.

Deltec Cozmo¿ Insulin Pumps are ambulatory electromechanical pumps used for delivering insulin to patients with diabetes. The pump is used mainly by homecare patients, but can also be used in a healthcare facility.
Code Information Product Numbers: 21-1705-79 21-1705-89 21-1706-79 21-1706-89 21-1707-79 21-1707-89 21-1715-19 21-1716-19 and 21-1717-19. 
Recalling Firm/
Manufacturer		 Smiths Medical MD, Inc.
1265 Grey Fox Rd
Saint Paul MN 55112-6929
For Additional Information Contact
651-628-7280
Manufacturer Reason
for Recall		 Smiths Medical has become aware of a display irregularity with the Deltec Cozmo¿ Insulin Pump, Model 1800 and Model 21-1700 containing Model 1800 software. There have been adverse events reported that the amount of Extended Bolus delivered was not accurately displayed by the Pump. The amount of extended Bolus displayed on the Pump Home Screen 2 and in the Bolus Summary Report is less than what w
FDA Determined
Cause 2		 Software design
Action Consignees were sent a Smiths Medical "Urgent Device Recall" letter dated November 20, 2008. The letter was addressed to Distributors, Clinicians, Patients and other Customers. The letter included a Description of the Problem, Advice on Action to be Taken by the User and requested the return of the Confirmation Form. In particular, users were given the option to check the "Replacement Pump" option on the Confirmation Form initiating the process for pump replacement with a recertified pump followed by a return of the defective product. The Confirmation Form can be faxed to 1-800-628-6322 in the U.S. or 1-651-628-7485 outside the U.S., completed at www.cozmore.com/notice or calling 1-800-501-5748 in the U.S.
Quantity in Commerce 586
Distribution Worldwide Distribution --- Including states of AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MI, MA, MD, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, WY and DC and countries of AUSTRALIA, NEW ZEALAND, UNITED KINGDOM, IRELAND, CANADA, CHINA, GREECE, POLAND, SLOVENIA, SWEDEN, ISRAEL and BRAZIL.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LZG and Original Applicant = SMITHS MEDICAL MD, INC.
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