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Medication Safety Alerts

Medtronic Infusion Sets Voluntary Recall

September 25, 2017

On September 25, 2017, Medtronic issued a voluntary recall of various infusion sets. This recall was issued because of a defective component that could cause the device to deliver too much insulin shortly after an infusion set change which could cause low blood sugar and in extreme cases, death.

This may represent a potential health hazard or safety risk to plan members who may be using product affected by this recall.

For detailed information about this recall, please visit:

https://www.medtronicdiabetes.com/notice7

For a list of potentially impacted products, please click here:

To find out if you have affected product, please visit:

https://checklots.medtronicdiabetes.com.

Medtronic recommends that members not use not use product affected by this recall. Medtronic will replace the recalled infusion sets free of charge. To see how you can return affected product, please visit:

https://www.medtronicdiabetes.com/customer-support/product-and-service-updates/notice7-letter-return-instructions

Medtronic recommends that you not use recalled infusion sets. You should replace any recalled infusion sets as soon as possible. However, if you only have recalled infusion sets right now, it is very important that you carefully follow the Key Steps for infusion set priming at https://www.medtronicdiabetes.com/priming.Please call your doctor right away for advice if you may be using affected product. Your doctor is familiar with your medical history and can suggest the best treatment option for you.

CVS Caremark Response: To support member safety, CVS Caremark is sending letters to members who received this product through CVS Caremark Mail Service Pharmacy and their physicians. Please call a Customer Care representative toll-free at 1-866-823-5184 for more information.

If you are currently using Medtronic infusion sets and have questions regarding this recall, please visit https://www.medtronicdiabetes.com/notice7 or call Medtronic toll-free at 1‑888-204-7616.You may also call the U.S. Food and Drug Administration (FDA) consumer inquiry line toll-free at 1‑888‑INFO‑FDA (1‑888‑463‑6332) or visit www.fda.gov.

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