Recall Z-0988-2009 ยท LZG Pump, Infusion, Insulin
Smiths Medical MD, Inc.
Deltec Cozmo Insulin Pump, Model 1800. 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.
| Date | Apr 16, 2009 (initiated Nov 20, 2008) |
| Status | Terminated |
| Reason | 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 |
| Root cause | 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 |
| Quantity | 16,461 |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K062323 | DELTEC COZMO INSULIN INFUSION PUMP WITH COZMONITOR BLOOD GLUCOSE METER, MODELS 21-1815, 21-1816, 21-1817 Smiths Medical MD, Inc., Nov 1, 2006 |