Recall Z-0601-2014
Asante Solutions, Inc. · initiated November 19, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Asante Conset Infusion Set with tubing & 9mm cannula packaged in 5-packs,singles,or inside a Combination Kit (FG-5249-4) Distributed by Asante Solutions, Sunnyvale, CA; Manufactured by Convatec; Lejre, Denmark.
Codes / lots: Asante Catalog number:FG-4249-5, FG-4249T; Unomedical Item number: 43-110-5269; Lot numbers: 0230129 5005804 5040412.
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.
FDA-determined cause: Device Design
Action taken
Asante sent urgent medical device recall notifications letters to distributors and customers on November 19, 2013 by US mail, return receipt requested.
Details
- Recall number
- Z-0601-2014
- Initiated
- November 19, 2013
- Posted by FDA
- December 27, 2013
- Terminated
- April 24, 2014
- Product code
- FPA – Set, Administration, Intravascular
- Quantity
- 1085 kits
- Distribution
- Nationwide Distribution.
- Recalling firm
- Asante Solutions, Inc., Sunnyvale, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| 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 |
| 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-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-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-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-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-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 |