Asante Solutions, Inc.
Asante Solutions, Inc. appears in FDA public data with 8 recalls, 2 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0598-2014, Class II) was initiated on November 19, 2013. Its most recent 510(k) clearance was granted on December 18, 2014.
Summary
- Total Recalls
- 8
- 510(k) Clearances
- 2
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-0598-2014 | Class II | Asante Conset Infusion Set with 60cm tubing & 6mm cannula packaged in 5-packs,singles,or inside a Co | November 19, 2013 |
| Z-0595-2014 | Class II | Asante Comfort Infusion Set with 60cm tubing & 17mm cannula packaged in 5-packs, singles,or inside a | November 19, 2013 |
| Z-0594-2014 | Class II | Asante Comfort Infusion Set with 60cm tubing & 13mm cannula packaged in 5-packs, singles,or inside a | November 19, 2013 |
| Z-0599-2014 | Class II | Asante Conset Infusion Set with 60cm tubing & 9mm cannula packaged in 5-packs,singles, or inside a C | November 19, 2013 |
| Z-0600-2014 | Class II | Asante Conset Infusion Set with 110cm tubing & 6mm cannula packaged in 5-packs, singles,or inside a | November 19, 2013 |
| Z-0597-2014 | Class II | Asante Comfort Infusion Set with 110cm tubing & 17mm cannula packaged in 5-packs, singles, or insid | November 19, 2013 |
| Z-0596-2014 | Class II | Asante Comfort Infusion Set with 110cm tubing & 13mm cannula packaged in 5-packs,singles, or inside | November 19, 2013 |
| Z-0601-2014 | Class II | Asante Conset Infusion Set with tubing & 9mm cannula packaged in 5-packs,singles,or inside a Combina | November 19, 2013 |