Z-0005-2013Class II

IR1200, IR1250(IR1200 Plus), 2020 and One Touch(R) Ping(R) Insulin Pump glucose management system. The device...

Name: Z-0005-2013 IR1200, IR1250(IR1200 Plus), 2020 and One Touch(R) Ping(R) Insulin Pump glucose management system. The device...
Creator: Animas Corporation
Published: 2012-07-16
License: https://open.fda.gov/license/

Animas Corp. / initiated 2012-07-16 / Terminated / root cause: manufacturing process

FDA source

Animas Corporation began a recall of IR1200, IR1250(IR1200 Plus), 2020 and One Touch(R) Ping(R) Insulin Pump glucose management system. The device is intended to deliver insulin therapy on 2012-07-16. FDA classified it as Class II and gives the reason as "Wear of the keypad that may lead to damage such as tearing or peeling of the edge of the keypad from the pump". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0005-2013
Classification: Class II
Status: Terminated
Initiated: 2012-07-16
Posted: 2012-10-02
Terminated: 2014-01-15
Recalling firm: Animas Corp.
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.
Product code: LZG Pump, Infusion, Insulin
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.
Root cause tag: manufacturing process
FDA root cause: 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0005-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0005-2013	Class II	Terminated	Voluntary: Firm initiated	2012-10-10	2012-10-02

Product code LZG

K032257Class IIModel Ir 1200 Insulin PumpAnimas Corp. / cleared 2003-10-16

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)