Reported Sep 16, 2015 · Terminated
OmniPod¿ Insulin Management System. Only the OmniPod¿ device is affected. Catalog Number(s): POD-ZXP420 (US). Intended…
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. Only the OmniPod¿ device is affected
- Catalog Number(s)POD-ZXP420 (US). Intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin
- Lot codes and dates
- Lot Numbers
L40806L40811L40895L40976L41014L41025L41067L41162L41171L41197L41198
- L41250 Expanded RecallLot
- Codes
L41880L41881L41892L41895L41897L41898L41899L41900L41901L41902L41903L41904L41905L41906L41907
- Lot Numbers
- Amount recalled
- 24829 boxes Expanded: 26,230.9 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
OmniPods¿ (Pods) have a higher rate of failure causing: Cannula fails to deploy/retract causing insulin to be pumped or the audible alarm is displayed on the PDM and pod will not deliver insulin
Using this product could cause serious injury, illness or death — stop using it now.
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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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