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Terminated

Animas Vibe Insulin Infusion Pump. This product is indicated for continuous subcutaneous infusion of insulin for the treatment of diabetes and has a continuous glucose monitoring feature.

FDA Recall Z-0136-2015 · Posted 2014-10-24

Recalling FirmAnimas Corporation
Recall StatusTerminated
Product CodeN/A
Date Initiated2014-06-10
Date Terminated2015-09-02
Product Quantity1028

Reason for Recall

Animas determined that the Hebrew language translation in the Vibe Insulin Infusion Pump was incorrect and could lead to potential patient confusion. In addition, one line of Hebrew text was omitted from the display screen.

Firm Action

A recall notification letter, dated June 2014, was sent to the recalling firm's sole customer, TriTech Biomed, in Israel, to notify them about the product, problem, and action to be taken. The distributor sent letters to their customers on July 16, 2014.

Root Cause

Employee error

Distribution Pattern

International Distribution in Israel only.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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