Z-2484-2015 Class I Terminated
FDA device recall Z-2484-2015 was initiated by Insulet Corporation on July 13, 2015 and is designated Class I. 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 The recall status is terminated (terminated January 26, 2017). Affected quantity: 24829 boxes Expanded: 26,230.9 boxes.
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
- 24829 boxes Expanded: 26,230.9 boxes
Product Description
OmniPod¿ Insulin Management System. Only the OmniPod¿ device is affected. Catalog Number(s): POD-ZXP420 (US). 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: L40806, L40811, L40895, L40976, L41014, L41025, L41067, L41162, L41171, L41197, L41198, L41250 Expanded Recall: Lot Codes: L41880, L41881, L41892, L41895,L41897,L41898, L41899,L41900, L41901, L41902, L41903, L41904, L41905, L41906, L41907