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.
Reported: September 16, 2015 Initiated: July 13, 2015 #Z-2485-2015
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
Details
- Recalling Firm
- Insulet Corporation
- Units Affected
- 16,017 boxes. Expanded Recall: 5,179.0 boxes
- Distribution
- Worldwide Distribution: US (Nationwide) and country of: Switzerland.
- Location
- Billerica, MA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Insulet Corporation. Units affected: 16,017 boxes. Expanded Recall: 5,179.0 boxes.
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 16, 2015. Severity: Critical. Recall number: Z-2485-2015.
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