Deltec Cozmo Insulin Pump, Model 1700, Product Catalog Numbers 21-1711-01, 21-1712-01 and 21-1713-01. The 3 versions var
FDA device recall Z-0798-03 · posted 2003-05-09 · Terminated
Recall details
- Recalling firm
- Deltec, Inc
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- LZG
- Quantity affected
- 913 pumps
- Distribution
- The product was distributed nationwide in the United States. There are no foreign or U.S. Government accounts.
- Date initiated
- 2003-03-14
- Date posted
- 2003-05-09
- Date terminated
- 2004-07-02
- Location
- St Paul, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DELTEC INSULIN INFUSION PUMP AND ACCESSORIES (K020655) | Deltec, Inc. | 2002-08-13 |