Reported Dec 23, 2015 · Terminated
OmniPod¿, Insulin Management System (OUS) Catalog Number: 14810 Product Usage: The OmnniPod¿ Insulin Management System…
Insulet Corporation
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Insulet Corporation · 600 Technology Park Dr Ste 200 · Billerica, MA · 01821-4126
Is this the product you have?
- OmniPod¿, Insulin
- Management System (OUS) Catalog Number14810
- Product UsageThe 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
- Lot codes and dates
- Lot Codes
L41908L41910F41935
- Lot Codes
- Amount recalled
- 5,179.0 boxes
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
Pod's needle mechanism fails to deploy or there is a delay in the deployment of the needle mechanism.
Using this product could cause serious injury, illness or death — stop using it now.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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