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Terminated

Animas 2020 Insulin Infusion Pump. Animas Corp. An insulin infusion.

FDA Recall Z-3017-2011 · Posted 2011-08-12

Recalling FirmAnimas Corporation
Recall StatusTerminated
Product CodeLZG
Date Initiated2011-07-29
Date Terminated2011-12-07
Product Quantity380

Reason for Recall

Incorrect component (1nF capacitor) was used to produce 191 printed circuit boards used in six pump lots of which 380 pumps were distributed. This issue may result in the pump displaying a "Replace Battery" alarm not related to the condition of the battery.

Firm Action

Animas Corporation sent an "Urgent: Insulin Pump Recall" letter dated July, 29 20011 to all affected customers. The letter included affected product and problem. They requested anyone who received the pump to send it back to Animas and a replacement pump will be sent at no charge. For additional information contact the Customer Support Department at (877) 937-7867.

Root Cause

Mixed-up of materials/components

Distribution Pattern

Worldwide Distribution: Nationwide (USA) distribution including the states of CA, CO, MA, and MD; and the countries of Australia, Finland, France, Israel, Italy, Sweden and the U.K.

Official Source

View FDA Recall →

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

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