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

FDA device recall Z-0005-2013 · posted 2012-10-02 · Terminated

Recall details

Recalling firm

Animas Corporation

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.

Action taken

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

Status

Terminated

Product code

LZG

Quantity affected

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

Date initiated

2012-07-16

Date posted

2012-10-02

Date terminated

2014-01-15

Location

West Chester, PA

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