Device product
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.
Z-2485-2015
Product summary
- Event
- Event 71651
- Status
- Terminated
- Classification
- Class I
- Quantity
- 16,017 boxes. Expanded Recall: 5,179.0 boxes
- Official record key
device-enforcement:Z-2485-2015
Official wording
Reason: 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
Code information: Lot Numbers: L40771, L40892, L40901, L40905, L40997, L41199, L41208 Expanded Recall: Lot Codes: L41908, L41910, F41935
Distribution pattern: Worldwide Distribution: US (Nationwide) and country of: Switzerland.
Derived failure modes
-
Unknown
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