Animas Corporation
Animas Corporation appears in FDA public data with 6 recalls — including 1 Class I (most serious) —, 0 510(k) clearances, 4 FDA inspections, and 1 compliance action on record. Its most recent recall (Z-0136-2015, Class II) was initiated on June 10, 2014.
Summary
- Total Recalls
- 6 (1 Class I)
- 510(k) Clearances
- 0
- Inspections
- 4
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-0136-2015 | Class II | Animas Vibe Insulin Infusion Pump. This product is indicated for continuous subcutaneous infusion | June 10, 2014 |
| Z-0993-2013 | Class I | Animas(R) 2020 Insulin Infusion Pump Product Usage: This product is indicated for continuous sub | January 3, 2013 |
| Z-0836-2013 | Class III | Animas(R) 2020, Animas(R) IR 1250 (1200 plus), Animas(R) IR 1200 Insulin Infusion Pumps Indicated f | December 17, 2012 |
| Z-0137-2015 | Class II | Animas Vibe Insulin Infusion Pump and System. These products are indicated for continuous subcuta | October 25, 2012 |
| Z-0005-2013 | Class II | IR1200, IR1250(IR1200 Plus), 2020 and One Touch(R) Ping(R) Insulin Pump glucose management system. | July 16, 2012 |
| Z-1034-2015 | Class II | Animas Vibe Insulin Infusion Pump. This product is indicated for continuous subcutaneous infusion | September 6, 2011 |