Animas(R) 2020, Animas(R) IR 1250 (1200 plus), Animas(R) IR 1200 Insulin Infusion Pumps Indicated for continuous subcuta
FDA device recall Z-0836-2013 · posted 2013-02-17 · Terminated
Recall details
- Recalling firm
- Animas Corporation
- Reason for recall
- Due to an internal calendar date limit (December 31, 2015) these pumps will cease to operate on January 1, 2016, and will result in a call service alarm that is displayed on the pump display.
- Action taken
- The firm initiated their recall of this product on December 17, 2012 by sending a letter to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact the Animas Customer Support Department at (866) 796-6373 for questions or concerns.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- LZG
- Quantity affected
- 37,998
- Distribution
- Worldwide Distribution-USA (nationwide) including Washington, DC, Puerto Rico, US Virgin Island and the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI
- Date initiated
- 2012-12-17
- Date posted
- 2013-02-17
- Date terminated
- 2013-12-24
- Location
- West Chester, PA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ANIMAS MODEL IR1250 INSULIN INFUSION PUMP (K042873) | Animas Corp. | 2004-12-10 |
| MODEL IR 1200 INSULIN PUMP (K032257) | Animas Corp. | 2003-10-16 |