Z-2485-2015 Class I Terminated
Recall Details
- Product Type
- Devices
- Report Date
- September 16, 2015
- Initiation Date
- July 13, 2015
- Termination Date
- January 26, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 16,017 boxes. Expanded Recall: 5,179.0 boxes
Product Description
OmniPod¿ Insulin Management System. Only the OmniPod¿ device is affected. Catalog Number(s): 14810 (OUS). Intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin.
Reason for Recall
OmniPods¿ (Pods) have a higher rate of failure causing: Cannula fails to deploy/retract causing insulin to be pumped or the audible alarm is displayed on the PDM and pod will not deliver insulin
Distribution Pattern
Worldwide Distribution: US (Nationwide) and country of: Switzerland.
Code Information
Lot Numbers: L40771, L40892, L40901, L40905, L40997, L41199, L41208 Expanded Recall: Lot Codes: L41908, L41910, F41935