| | Class 2 Recall
2.0 mL Cartridge/Syringe Piston component of Insulin Pump |  |
| Date Posted |
May 10, 2011 |
| Recall Number |
Z-1678-2011 |
| Product |
2.0 mL Cartridge/Syringe Piston component of Insulin Pump
Insulin infusion |
| Code Information |
Lot numbers -- US: B201575, B201576, B201581, B201582, Exp. 7/31/2012; B201583, Exp. 8/31/2012; FRANCE: B201580, Exp. 7/31/2012.
|
Recalling Firm/
Manufacturer |
Animas Corporation
200 Lawrence Dr
West Chester, Pennsylvania 19380-3428 |
| For Additional Information Contact |
Jon Mulberg
408-942-5937
|
Reason for
Recall |
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.
|
| 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 1-877-280-2339.
Customers were instructed to notify the firm by logging on to the following website: www.animasnotification.com or call the Call Center at 1-877-280-2339 if they have no product to return. |
| Quantity in Commerce |
384,180 |
| Distribution |
Worldwide Distribution - USA (nationwide) and France. |
| |
|
|
|
|
