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U.S. Department of Health and Human Services

Class 2 Device Recall OneTouch(R) Ping(R) Insulin Pump glucose management system

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  Class 2 Device Recall OneTouch(R) Ping(R) Insulin Pump glucose management system see related information
Date Initiated by Firm March 01, 2012
Date Posted April 06, 2012
Recall Status1 Terminated 3 on December 24, 2013
Recall Number Z-1376-2012
Recall Event ID 61436
510(K)Number K080639  
Product Classification Pump, infusion, insulin - Product Code LZG
Product OneTouch(R) Ping(R) Insulin Pump glucose management system. The device is intended to deliver insulin therapy.
Code Information Part number 101420-00, 10142100, 101422-00, 101424-00, 101425-00, 100430-00, 100431-00, 100432-00, 100434-00, 100435-00, 101420-98, 101421-98, 101422-98, 101424-98, 101425-98, and 10050000.
Recalling Firm/
Manufacturer		 Animas Corporation
200 Lawrence Dr
West Chester PA 19380-3428
For Additional Information Contact Jon Mulberg
610-644-8900
Manufacturer Reason
for Recall		 There is an error in the pump software where the OneTouch(R) Ping(R) insulin pump did not allow the user to save changes to the time and date on the pump if those changes were made on February 29, 2012 (Leap Day). Users who did not attempt to change the time or date on their pump on February 29, 2012 are not affected by this issue.
FDA Determined
Cause 2		 Software design
Action The firm initiated their recall on March 1, 2012 and sent Urgent Notification letters dated March 6, 2012 to all consignees by UPS with delivery confirmation. Customers were notified of the issue and the appropriate steps to take in order to mitigate the issue. A Web Letter for users was also posted to the Animas web site. Questions were directed to (855) 230-7577.
Quantity in Commerce 91,239
Distribution Worldwide Distribution, (USA) including the states of AK, AL, AR, AZ, CA, CO, CT, DC, 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, SC, TN, TX, UT, VA, VT, WA, WI, WV, WY and the country of Canada and the territory of Puerto Rico.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LZG and Original Applicant = ANIMAS CORP.
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