Recall Z-0594-2014— Asante Solutions, Inc.

Name: FDA recall Z-0594-2014
Creator: U.S. Food and Drug Administration
Published: 2013-11-19

Class II · Terminated

Class II FDA medical device recall by Asante Solutions, Inc., initiated 2013-11-19, terminated 2014-04-24. It names one FDA 510(k) clearance: K120872. 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: 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..

Recalling firm: Asante Solutions, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-11-19
Terminated: 2014-04-24
Firm location: Sunnyvale, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K120872 — ASANTE CONSET AND ASANTE COMFORT SUBCUTANEOUS INFUSION SETS FOR USE WITH ASANTE PEARL INFUSION PUMPSUnomedical A/S Infusion Devices·cleared 2012-04-20

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product 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 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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.