Recall Z-0210-05 ยท LZG Pump, Infusion, Insulin
Smiths Medical MD, Inc.
Deltec Cozmo Insulin Pump
| Date | Nov 19, 2004 (initiated Sep 18, 2004) |
| Status | Terminated |
| Reason | The vibratory alarm motor installed in a small number of Deltec Cozmo Insulin Pumps may function intermittently. |
| Root cause | Other |
| Action | All customers were contacted and instructed to only use the Beeper alarm function and not the vibrate alarm feature. Patients were instructed to return the affected pump to Smiths Medical MD upon receipt of the replacement pump. |
| Quantity | 6 pumps to patients and 30 pumps in France |
| Distribution | 371 = Number of Individual Product Manufactured 6 = Number of Product Distributed to Patients 365 = Number of Products Either at Smiths Medical MD or at the Distributor or with a Smiths Medical MD Sales Rep. |
| 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 |