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Terminated

IR1200, IR1250(IR1200 Plus), 2020 and One Touch(R) Ping(R) Insulin Pump glucose management system. The device is intended to deliver insulin therapy.

FDA Recall Z-0005-2013 · Posted 2012-10-02

Recalling FirmAnimas Corporation
Recall StatusTerminated
Product CodeLZG
Date Initiated2012-07-16
Date Terminated2014-01-15
Product Quantity236,470

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.

Firm 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.

Root Cause

Nonconforming Material/Component

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K032257MODEL IR 1200 INSULIN PUMPAnimas Corp. · 2003-10-16

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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