Asante Conset Infusion Set with tubing & 9mm cannula packaged in 5-packs,singles,or inside a Combination Kit (FG-5249-4)
FDA device recall Z-0601-2014 · posted 2013-12-27 · Terminated
Recall details
- Recalling firm
- Asante Solutions, Inc.
- 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.
- Action taken
- Asante sent urgent medical device recall notifications letters to distributors and customers on November 19, 2013 by US mail, return receipt requested.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- FPA
- Quantity affected
- 1085 kits
- Distribution
- Nationwide Distribution.
- Date initiated
- 2013-11-19
- Date posted
- 2013-12-27
- Date terminated
- 2014-04-24
- Location
- Sunnyvale, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ASANTE CONSET AND ASANTE COMFORT SUBCUTANEOUS INFUSION SETS FOR USE WITH ASANTE PEARL INFUSION PUMPS (K120872) | Unomedical A/S Infusion Devices | 2012-04-20 |