Z-0393-2016 Class I Terminated
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