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.
Reported: December 23, 2015 Initiated: November 2, 2015 #Z-0393-2016
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.
Details
- Recalling Firm
- Insulet Corporation
- Units Affected
- 26,230.9 boxes
- Distribution
- Worldwide Distribution - US Nationwide and countries of Switzerland, Germany, and Israel.
- Location
- Billerica, MA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Insulet Corporation. Units affected: 26,230.9 boxes.
Why was this product recalled? ▼
Pod's needle mechanism fails to deploy or there is a delay in the deployment of the needle mechanism.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 23, 2015. Severity: Critical. Recall number: Z-0393-2016.
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