Recall Z-0836-2013— Animas Corporation

Name: FDA recall Z-0836-2013
Creator: U.S. Food and Drug Administration
Published: 2012-12-17

Class III · Terminated

Class III FDA medical device recall by Animas Corporation, initiated 2012-12-17, terminated 2013-12-24. It names 2 FDA 510(k) clearances: K042873, K032257. Product: Animas(R) 2020, Animas(R) IR 1250 (1200 plus), Animas(R) IR 1200 Insulin Infusion Pumps Indicated for continuous subcutaneous infusion of insulin.. Reason: Due to an internal calendar date limit (December 31, 2015) these pumps will cease to operate on January 1, 2016, and will result in a call service alarm that is displayed on the pump display..

Recalling firm: Animas Corporation
Classification: Class III
Status: Terminated
Initiated: 2012-12-17
Terminated: 2013-12-24
Firm location: West Chester, PA, United States

510(k) clearances named in this recall

2 on FDA's record

K042873 — ANIMAS MODEL IR1250 INSULIN INFUSION PUMPAnimas Corp.·cleared 2004-12-10
K032257 — MODEL IR 1200 INSULIN PUMPAnimas Corp.·cleared 2003-10-16

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Animas(R) 2020, Animas(R) IR 1250 (1200 plus), Animas(R) IR 1200 Insulin Infusion Pumps Indicated for continuous subcutaneous infusion of insulin.

Reason for recall

Due to an internal calendar date limit (December 31, 2015) these pumps will cease to operate on January 1, 2016, and will result in a call service alarm that is displayed on the pump display.

Data sourced from openFDA. This site is unofficial and independent of the FDA.