Recall Z-0595-2014 ยท FPA Set, Administration, Intravascular
Asante Solutions, Inc.
Asante Comfort Infusion Set with 60cm tubing & 17mm cannula packaged in 5-packs, singles,or inside a Combination Kit (FG-5127-4). Manufactured for: Asante Solutions Sunnyvale, CA; Manufactured by: Unomedical Lejre, Denmark
| Date | Dec 27, 2013 (initiated Nov 19, 2013) |
| Status | Terminated |
| 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 | 246 kits |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K120872 | ASANTE CONSET AND ASANTE COMFORT SUBCUTANEOUS INFUSION SETS FOR USE WITH ASANTE PEARL INFUSION PUMPS Unomedical A/S Infusion Devices, Apr 20, 2012 |