Recall Z-0393-2016— Insulet Corporation
Class I · Terminated
Class I FDA medical device recall by Insulet Corporation, initiated 2015-11-02, terminated 2017-03-07. It names one FDA 510(k) clearance: K122953. Product: 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: Pod's needle mechanism fails to deploy or there is a delay in the deployment of the needle mechanism..
- Recalling firm
- Insulet Corporation
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2015-11-02
- Terminated
- 2017-03-07
- Firm location
- Billerica, MA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.