Z-0005-2013 Class II Terminated
FDA device recall Z-0005-2013 was initiated by Animas Corporation on July 16, 2012 and is designated Class II. 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. The recall status is terminated (terminated January 15, 2014). Affected quantity: 236,470.
Recall Details
- Product Type
- Devices
- Report Date
- October 10, 2012
- Initiation Date
- July 16, 2012
- Termination Date
- January 15, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 236,470
Product Description
Reason for Recall
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.