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[Recalled] Animas Vibe Insulin Infusion Pump and System. These products are indicated for continuous subcutaneous infusion of insulin for the treatment of insulin-requiring diabetes. — Animas determined that keypad wear over time was con

recall fda device united-states

The product on this page is subject to an official recall. We summarise the regulator's findings and the recommended action.

Recall details

ProductAnimas Vibe Insulin Infusion Pump and System. These products are indicated for continuous subcutaneous infusion of insulin for the treatment of insulin-requiring diabetes.
Brand / manufacturerAnimas Corporation
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-0137-2015
Country of noticeUnited States
Risk levelClass II
Hazard typerecall
Notice date25 October 2012

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: Animas determined that keypad wear over time was contributing to an increased complaint rate associated with damaged keypads on the Vibe Insulin Infusion Pump and System. Animas has implemented an improvement to the keypad related to the material used to reduce susceptibility to damage and increase durability.

This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

Related recalls from Animas Corporation

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.

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