Z-0393-2016 Class I Terminated
FDA device recall Z-0393-2016 was initiated by Insulet Corporation on November 2, 2015 and is designated Class I. Reason for recall: Pod's needle mechanism fails to deploy or there is a delay in the deployment of the needle mechanism. The recall status is terminated (terminated March 7, 2017). Affected quantity: 26,230.9 boxes.
Recall Details
- Product Type
- Devices
- Report Date
- December 23, 2015
- Initiation Date
- November 2, 2015
- Termination Date
- March 7, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 26,230.9 boxes
Product Description
OmniPod¿, Insulin Management System (US) Catalog Number: PODZXP420 Product Usage: The OmnniPod¿ Insulin Management System is intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin and for the quantitative measurement of glucose in fresh whole capillary blood (in vitro) from the finger.
Reason for Recall
Pod's needle mechanism fails to deploy or there is a delay in the deployment of the needle mechanism.
Distribution Pattern
Worldwide Distribution - US Nationwide and countries of Switzerland, Germany, and Israel.
Code Information
Lot Codes: L41880, L41881, L41892, L41895,L41897,L41898, L41899,L41900, L41901, L41902, L41903, L41904, L41905, L41906, L41907