Recall Z-0566-05 ยท LZG Pump, Infusion, Insulin
Smiths Medical MD, Inc.
Deltec Cozmo 3 ml Insulin Cartridge with 0.7mm(22G) x 12.5mm (1/2 in.) needle and cap. Reorder No. 21-1750-24. Immediate container states STERILE EO, Rx Only , Deltec, Inc., St. Paul, MN 55112. Additional labeling states Cartridge is Sterile and nonpyrogenic unless package is opened or damaged. do not use if package is opened or damaged, or if product appears damaged. Made in Mexico for:
| Date | Feb 26, 2005 (initiated Oct 15, 2004) |
| Status | Terminated |
| Reason | Smiths Medical MD, Inc. (SMMD) has received several complaints relating to two lots of Cozmo Cartridges describing leakage of insulin into the cartridge chamber. Firm expanded recall 03/17/05 to include one more lot, based on in-house testing and review of customer complaints. |
| Root cause | Other |
| Action | Consignees were mailed Customer Recall Notification Letter on 10/15/04. Customers are to inspect their inventory for the affected lot numbers and contact Smiths Medical Customer Services Department and return any unused Insulin Cartridges to Smiths Medical, who will replace the returned Insulin Cartridges. EXPANDED RECALL Customers were notified with an Urgent: Product Safety & Recall Notification beginning 03/17/05 with similar instructions as in the previous Notification. Customers are to inspect their inventory for the affected lot number, contact Smiths Medical Diabetes System Customer |
| Quantity | 2886 boxes (25 cartridges per box); EXPANDED RECALL additional 1440 boxes |
| Distribution | nationwide. Product only distributed within the US. |
| 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 |