Recall Z-0005-2013— Animas Corporation

Name: FDA recall Z-0005-2013
Creator: U.S. Food and Drug Administration
Published: 2012-07-16

Class II · Terminated

Class II FDA medical device recall by Animas Corporation, initiated 2012-07-16, terminated 2014-01-15. It names one FDA 510(k) clearance: K032257. Product: IR1200, IR1250(IR1200 Plus), 2020 and One Touch(R) Ping(R) Insulin Pump glucose management system. The device is intended to deliver insulin therapy.. Reason: Wear of the keypad that may lead to damage such as tearing or peeling of the edge of the keypad from the pump..

Recalling firm: Animas Corporation
Classification: Class II
Status: Terminated
Initiated: 2012-07-16
Terminated: 2014-01-15
Firm location: West Chester, PA, United States

510(k) clearances named in this recall

1 on FDA's record

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

IR1200, IR1250(IR1200 Plus), 2020 and One Touch(R) Ping(R) Insulin Pump glucose management system. The device is intended to deliver insulin therapy.

Reason for recall

Wear of the keypad that may lead to damage such as tearing or peeling of the edge of the keypad from the pump.

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