FDA Medical Device Recalls (openFDA)
Animas Corporation: OneTouch(R) Ping(R) Insulin Pump glucose management system. The device is intended to deliver insulin therapy.
- Recall number
- Z-1376-2012
- Recalling firm
- Animas Corporation
- Product
- OneTouch(R) Ping(R) Insulin Pump glucose management system. The device is intended to deliver insulin therapy.
- Status
- Terminated
- Initiated
- 2012-03-01
- Posted
- 2012-04-06
- Terminated
- 2013-12-24
- Reason
- 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
- 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
- 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.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K080639"]
- PMA numbers
- not on file
- Product code
- LZG
- Firm FEI
- 3002920072
- Firm city
- West Chester
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28