OneTouch(R) Ping(R) Insulin Pump glucose management system. The device is intended to deliver insulin therapy.
FDA Recall Z-1376-2012 · Posted 2012-04-06
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Recalling FirmAnimas Corporation
Recall StatusTerminated
Product CodeLZG
Date Initiated2012-03-01
Date Terminated2013-12-24
Product Quantity91,239
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.
Firm 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.
Root Cause
Software design
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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