Class 2 Device Recall Insulin Infusion Pump

• Date Initiated by Firm: February 22, 2008
• Date Posted: September 01, 2008
• Recall Status: Terminated on January 19, 2011
• Recall Number: Z-1590-2008
• Recall Event ID: 47423
• 510(K)Number: K020655 K031738
• Product Classification: Infusion Pump - Product Code LZG
• Product: Deltec Cozmo¿ Insulin Pump, model 21-1700.; A syringe infusion pump designed for Continuous Subcutaneous Insulin Infusion for the control of diabetes.; ; Reorder Numbers:; 21-1701-02/32/33/36/44/49/51/54/62/63/66/81; 21-1702-02//49/51; 21-1703-02/32/33/36/44/49/51/54/62/63/66/81; 21-1704-02/32/33/36/44/49/51/54/62/63/66/81; 21-1705-79; 21-1706-79; 21-1707-79; 21-1711-01/02/03/06/14/50; 21-1712-01/02; 21-1713-01/02/03/06/14/50; 21-1714-01/02/03/06/14/50; 21-1715-19; 21-1716-19; 21-1717-19
• Code Information: all serial numbers
• 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: 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
• FDA Determined Cause: Device Design
• 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.
• 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.
• 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 = DELTEC, INC.; 510(K)s with Product Code = LZG and Original Applicant = SMITHS MEDICAL MD, INC.