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

FDA device recall Z-3017-2011 · posted 2011-08-12 · Terminated

Recall details

Recalling firm

Animas Corporation

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.

Action taken

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

Status

Terminated

Product code

LZG

Quantity affected

380

Distribution

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.

Date initiated

2011-07-29

Date posted

2011-08-12

Date terminated

2011-12-07

Location

West Chester, PA