FDA Recall
Terminated
Asante Comfort Infusion Set with 60cm tubing & 13mm cannula packaged in 5-packs, singles,or inside a Combination Kit (FG-5123-4) Manufactured for: Asante Solutions Sunnyvale, CA; Manufactured by: Unomedical Lejre, Denmark
Recall: Z-0594-2014
·
Initiated November 19, 2013
Recall
- Recall Number
- Z-0594-2014
- Event Number
- 66895
- Firm
- Asante Solutions, Inc.
- FEI Number
- 3009351200
- Product Code
- FPA
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- November 19, 2013
- Posted
- December 27, 2013
- Terminated
- April 24, 2014
- Address
- 352 E Java Dr, Sunnyvale, CA, 94089-1328
Description
Asante Comfort Infusion Set with 60cm tubing & 13mm cannula packaged in 5-packs, singles,or inside a Combination Kit (FG-5123-4) Manufactured for: Asante Solutions Sunnyvale, CA; Manufactured by: Unomedical 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.
Action
Asante sent urgent medical device recall notifications letters to distributors and customers on November 19, 2013 by US mail, return receipt requested.
Distribution
Nationwide Distribution.
Quantity
834 kits