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U.S. Department of Health and Human Services

Class 2 Device Recall IR1200, IR1250(IR1200 Plus), 2020 and One Touch(R) Ping(R) Insulin Pump

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 Class 2 Recall
IR1200, IR1250(IR1200 Plus), 2020 and One Touch(R) Ping(R) Insulin Pump
see related information
Date Posted October 02, 2012
Recall Status1 Terminated on January 15, 2014
Recall Number Z-0005-2013
Recall Event ID 61780
Premarket Notification
510(K) Number
K032257 
Product Classification Pump, Infusion, Insulin - Product Code LZG
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.
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.
Recalling Firm/
Manufacturer
Animas Corporation
200 Lawrence Dr
West Chester, Pennsylvania 19380-3428
For Additional Information Contact Jon Mulberg
610-644-8900
Manufacturer 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.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action The firm, Animas Corporation, sent an "IMPORTANT PATIENT NOTIFICATION" letter dated July 16, 2012 to its consignees/customers. The letter described the product, problem and actions to be taken. The consignees/customers were instructed to examine their insulin pump for wear or damage on a regular basis, as part of their routine process of inspecting their pump. If keypad is worn or damaged, the buttons may not respond as intended. If consignees/customers see any damage or have issues with the keypad, they are to contact Animas through their website at www.animas.com/contact-animas or telephone Animas Customer Technical Support at 1-855-230-7574, or the phone number provided on the back of their insulin pump. Animas carefully investigates all complaints related to the insulin pump keypad. If you have any questions contact Animas Customer Technical Support at 1-855-230-7574.
Quantity in Commerce 236,470
Distribution 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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = LZG and Original Applicant = ANIMAS CORP.
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