Asante Comfort Infusion Set with 60cm tubing & 13mm cannula packaged… — Class II medical device recall Z-0594-2014
Terminated recall by Asante Solutions, Inc., reported 2014-01-08, distributed nationwide. Reports of the infusion tubing disconnecting from the connector, resulting in leakage of insulin from the infu
| Recall number | Z-0594-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Asante Solutions, Inc., Sunnyvale, CA, United States |
| Recall initiated | 2013-11-19 |
| Classified | 2013-12-27 |
| Reported by FDA | 2014-01-08 |
| Terminated | 2014-04-24 |
| Distributed | Nationwide (US) |
| Quantity | 834 kits |
| Reason classes | packaging |
| Lot numbers | 0230118, 0230122, 5036994 |
| Model numbers | 87-060-2562, FG-4123-5, FG-4123T |
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
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0594-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.