Asante Solutions, Inc.
Medical device manufacturer in Sunnyvale, CA.
2510(k) clearances
0PMA approvals
8recalls
Device types
510(k) clearances
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0601-2014 Class II | Asante Conset Infusion Set with tubing & 9mm cannula packaged in 5-packs,singles,or…Reports of the infusion tubing disconnecting from the connector, resulting in leakage of insulin from the… | 11/19/2013Terminated |
| Z-0600-2014 Class II | Asante Conset Infusion Set with 110cm tubing & 6mm cannula packaged in 5-packs…Reports of the infusion tubing disconnecting from the connector, resulting in leakage of insulin from the… | 11/19/2013Terminated |
| Z-0599-2014 Class II | Asante Conset Infusion Set with 60cm tubing & 9mm cannula packaged in 5-packs,singles…Reports of the infusion tubing disconnecting from the connector, resulting in leakage of insulin from the… | 11/19/2013Terminated |
| Z-0598-2014 Class II | Asante Conset Infusion Set with 60cm tubing & 6mm cannula packaged in 5-packs,singles,or…Reports of the infusion tubing disconnecting from the connector, resulting in leakage of insulin from the… | 11/19/2013Terminated |
| Z-0597-2014 Class II | Asante Comfort Infusion Set with 110cm tubing & 17mm cannula packaged in 5-packs…Reports of the infusion tubing disconnecting from the connector, resulting in leakage of insulin from the… | 11/19/2013Terminated |
| Z-0596-2014 Class II | Asante Comfort Infusion Set with 110cm tubing & 13mm cannula packaged in…Reports of the infusion tubing disconnecting from the connector, resulting in leakage of insulin from the… | 11/19/2013Terminated |
| Z-0595-2014 Class II | Asante Comfort Infusion Set with 60cm tubing & 17mm cannula packaged in 5-packs…Reports of the infusion tubing disconnecting from the connector, resulting in leakage of insulin from the… | 11/19/2013Terminated |
| Z-0594-2014 Class II | Asante Comfort Infusion Set with 60cm tubing & 13mm cannula packaged in 5-packs…Reports of the infusion tubing disconnecting from the connector, resulting in leakage of insulin from the… | 11/19/2013Terminated |