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Omnipod Insulin Management System (2014-03-07)
- Starting date:
- March 7, 2014
- Posting date:
- March 25, 2014
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type I
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-38629
Recalled Products
Omnipod Insulin Management System
Reason
The Freestyle blood glucose test strips when used with the Freestyle blood glucose meter built into the Omnipod Insulin Management system may produce erroneously low blood glucose results. Erroneously low results that are not recognized may pose significant risks to a user's health.
Affected products
Omnipod Insulin Management System
Lot or serial number
CAT45E
CAT45F
PDM-CAT35E
PDM-CAT35F
Model or catalog number
All lots
Companies
- Manufacturer
-
Insulet Corporation
9 Oak Park Drive
Bedford
01730
Massachusetts
UNITED STATES