Recall Z-0798-03 ยท LZG Pump, Infusion, Insulin
Deltec, Inc
Deltec Cozmo Insulin Pump, Model 1700, Product Catalog Numbers 21-1711-01, 21-1712-01 and 21-1713-01. The 3 versions vary only in the color of the exterior.
| Date | May 9, 2003 (initiated Mar 14, 2003) |
| Status | Terminated |
| Reason | A software error could have resulted in the delivery of a larger bolus of insulin than anticipated when the pump was programmed in a particular manner. |
| Root cause | Other |
| Action | Recall Notification letters were sent to the consignees on March 14, 2003. The letters gave recommendations for avoiding the problem, stated that updated software to prevent the problem would be introduced, and requested that the customer call a toll-free phone number to arrange replacement of their affected pump. |
| Quantity | 913 pumps |
| Distribution | The product was distributed nationwide in the United States. There are no foreign or U.S. Government accounts. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K020655 | DELTEC INSULIN INFUSION PUMP AND ACCESSORIES Deltec, Inc., Aug 13, 2002 |