Recall Z-1678-2011 ยท LZG Pump, Infusion, Insulin
Animas Corporation
2.0 mL Cartridge/Syringe Piston component of Insulin Pump Insulin infusion
| Date | May 10, 2011 (initiated Feb 25, 2011) |
| Status | Terminated |
| Reason | Action is being undertaken to address the occurrence of adverse events associated with leaking cartridges. Firm became aware of this issue through customer complaints from pump users reporting the cartridges were leaking. |
| Root cause | Material/Component Contamination |
| Action | Animas Corporation sent an Urgent Recall letter dated February 22, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to: Change their cartridge immediately using the instructions provided. Return all of the unused affected product using the enclosed box. Shipments must be returned using the United States Postal Service. For technical questions call Animas Customer Support at 1-855-254-5668 or call the toll free number at 1-8777-937-7867. For any questions about returning the product call |
| Quantity | 384,180 |
| Distribution | Worldwide Distribution - USA (nationwide) and France. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K032257 | MODEL IR 1200 INSULIN PUMP Animas Corp., Oct 16, 2003 |