Recall Z-0993-2013— Animas Corporation

Name: FDA recall Z-0993-2013
Creator: U.S. Food and Drug Administration
Published: 2013-01-03

Class I · Terminated

Class I FDA medical device recall by Animas Corporation, initiated 2013-01-03, terminated 2015-05-14. It names one FDA 510(k) clearance: K042873. Product: Animas(R) 2020 Insulin Infusion Pump Product Usage: This product is indicated for continuous subcutaneous infusion of insulin for the treatment of insulin-requiring diabetes.. Reason: Animas has identified a component issue affecting a small supply of the Animas(R) 2020 insulin pumps. The component issue may trigger the pumps to sound a false alarm or warning related to one of the following: - Loss of prime; -Occlusion; or -No cartridge detected..

Recalling firm: Animas Corporation
Classification: Class I
Status: Terminated
Initiated: 2013-01-03
Terminated: 2015-05-14
Firm location: West Chester, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K042873 — ANIMAS MODEL IR1250 INSULIN INFUSION PUMPAnimas Corp.·cleared 2004-12-10

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 Insulin Infusion Pump Product Usage: This product is indicated for continuous subcutaneous infusion of insulin for the treatment of insulin-requiring diabetes.

Reason for recall

Animas has identified a component issue affecting a small supply of the Animas(R) 2020 insulin pumps. The component issue may trigger the pumps to sound a false alarm or warning related to one of the following: - Loss of prime; -Occlusion; or -No cartridge detected.

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