Recall Z-0598-2014— Asante Solutions, Inc.
Class II · Terminated
Class II FDA medical device recall by Asante Solutions, Inc., initiated 2013-11-19, terminated 2014-04-24. FDA's recall record names no specific 510(k) clearance for this event. Product: Asante Conset Infusion Set with 60cm tubing & 6mm cannula packaged in 5-packs,singles,or inside a Combination Kit (FG-5226-4) Distributed by Asante Solutions, Sunnyvale, CA; Manufactured by Convatec; Lejre, Denmark.. Reason: Reports of the infusion tubing disconnecting from the connector, resulting in leakage of insulin from the infusion set and providing patient with less insulin than intended..
- Recalling firm
- Asante Solutions, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-11-19
- Terminated
- 2014-04-24
- Firm location
- Sunnyvale, CA, United States
Product description
Asante Conset Infusion Set with 60cm tubing & 6mm cannula packaged in 5-packs,singles,or inside a Combination Kit (FG-5226-4) Distributed by Asante Solutions, Sunnyvale, CA; Manufactured by Convatec; Lejre, Denmark.
Reason for recall
Reports of the infusion tubing disconnecting from the connector, resulting in leakage of insulin from the infusion set and providing patient with less insulin than intended.
Data sourced from openFDA. This site is unofficial and independent of the FDA.