FDA Medical Device Recalls (openFDA)
Asante Solutions, Inc.: 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 number
- Z-0594-2014
- Recalling firm
- Asante Solutions, Inc.
- Product
- 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
- Status
- Terminated
- Initiated
- 2013-11-19
- Posted
- 2013-12-27
- Terminated
- 2014-04-24
- 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.
- Root cause
- Device Design
- Action
- Asante sent urgent medical device recall notifications letters to distributors and customers on November 19, 2013 by US mail, return receipt requested.
- Quantity
- 834 kits
- Distribution
- Nationwide Distribution.
- Lot, serial or model codes
- Asante Catalog number: FG-4123-5 FG-4123T Unomedical Item number: 87-060-2562; Lot numbers: 0230118 0230122 5036994
- 510(k) numbers
- ["K120872"]
- PMA numbers
- not on file
- Product code
- FPA
- Firm FEI
- 3009351200
- Firm city
- Sunnyvale
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28