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U.S. Department of Health and Human Services

Enforcement Report - Week of October 10, 2012

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Product Detail

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.
Recall Number Z-0005-2013
Classification Class II
Code Info OneTouch(R) Ping(TM) Glucose Management Systems - Part Numbers 101420-00, 101421-00, 101422-00, 101424-00, 101425-00, 100430-00, 100431-00, 100432-00, 100434-00, 100435-00, 101420-98, 101421-98, 101422-98, 101424-98, and 101425-98; Animas(R) 2020 Insulin Infusion Pumps - Part numbers 101370-00, 101371-00, 101372-00, 101374-00, 101375-00, 100380-00, 100381-00, 100382-00, 100384-00, and 100385-00; Animas(R) IR 1250 (1200 Plus) Insulin Infusion Pumps -- Part numbers 100250-00, 100251-00, and 100252-00; and Animas(R) IR 1200 Insulin Infusion Pumps - Part numbers 100200-00, 100201-00, and 100202-00. Serial numbers -- will be provided.
Product Distributed Qty 236,470
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.

Event Detail

Event Id 61780
Product Type Devices
Status Ongoing
Recalling Firm Animas Corporation
City West Chester
State PA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-07-16
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide distribution: USA (nationwide) including states of: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, V, VT, WA, WI, WV, WY and Washington, DC and countries of: Austria, Australia, Canada, Czech Republic, France, Finland, Germany, Hungary, Israel, Italy, Mexico, New Zealand, Puerto Rico, Spain, and United Kingdom.