Animas Corporation

FDA Regulatory Profile

Summary

Total Recalls
6 (1 Class I)
510(k) Clearances
0
Inspections
4
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-0136-2015Class IIAnimas Vibe Insulin Infusion Pump. This product is indicated for continuous subcutaneous infusionJune 10, 2014
Z-0993-2013Class IAnimas(R) 2020 Insulin Infusion Pump Product Usage: This product is indicated for continuous subJanuary 3, 2013
Z-0836-2013Class IIIAnimas(R) 2020, Animas(R) IR 1250 (1200 plus), Animas(R) IR 1200 Insulin Infusion Pumps Indicated fDecember 17, 2012
Z-0137-2015Class IIAnimas Vibe Insulin Infusion Pump and System. These products are indicated for continuous subcutaOctober 25, 2012
Z-0005-2013Class IIIR1200, IR1250(IR1200 Plus), 2020 and One Touch(R) Ping(R) Insulin Pump glucose management system. July 16, 2012
Z-1034-2015Class IIAnimas Vibe Insulin Infusion Pump. This product is indicated for continuous subcutaneous infusionSeptember 6, 2011