Z-1376-2012

OneTouch(R) Ping(R) Insulin Pump glucose management system. The device is intended to deliver insulin therapy

Name: Z-1376-2012 OneTouch(R) Ping(R) Insulin Pump glucose management system. The device is intended to deliver insulin therapy
Creator: Animas Corporation
Published: 2012-03-01
License: https://open.fda.gov/license/

Animas Corp. / initiated 2012-03-01 / Terminated / root cause: software

FDA source

Animas Corporation began a recall of OneTouch(R) Ping(R) Insulin Pump glucose management system. The device is intended to deliver insulin therapy on 2012-03-01. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1376-2012
Status: Terminated
Initiated: 2012-03-01
Posted: 2012-04-06
Terminated: 2013-12-24
Recalling firm: Animas Corp.
Product: OneTouch(R) Ping(R) Insulin Pump glucose management system. The device is intended to deliver insulin therapy.
Product code: LZG Pump, Infusion, Insulin
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.
Root cause tag: software
FDA root cause: 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.
Product codes and lots: 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.

Product code LZG

K080639Class IISymphony Glucose Management SystemAnimas Corp. / cleared 2008-06-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)