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Terminated

Animas ezManager Max Diabetes Management System version 2.0.9

FDA Recall Z-0481-2010 · Posted 2009-12-03

Recalling FirmAnimas Corporation
Recall StatusTerminated
Product CodeMRZ
Date Initiated2009-11-02
Date Terminated2010-10-27
Product Quantity20,648 units

Reason for Recall

Printed hard copy of results is not the same as the system screens- carbohydrate to insulin ratio incorrect.

Firm Action

Animas issued an Urgent Medical Device Correction letter dated 11/2/09 to the pump user and another letter to the health care professional that prescribed the pump. The letters explain the issue. The patient letter is accompanied with a CD that contains the upgraded software and instructions to follow.

Root Cause

Software design

Distribution Pattern

Nationwide distribution, and Canada, Cayman Islands, and Denmark.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K080587EZ MANAGER MAX DIABETES MANAGEMENT SOFTWAREAnimas Corp. · 2008-05-15

Official Source

View FDA Recall →

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

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