Z-0005-2013 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- October 10, 2012
- Initiation Date
- July 16, 2012
- Termination Date
- January 15, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 236,470
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.
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.
Code Information
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.