Asante Comfort Infusion Set with 110cm tubing & 17mm cannula packaged in 5-packs, singles, or inside a Combination Kit (FG-5147-4). Manufactured for: Asante Solutions Sunnyvale, CA; Manufactured by: Unomedical, Lejre, Denmark

This recall has been terminated (originally issued December 27, 2013).

Company: Asante Solutions, Inc.
Recall Initiated: November 19, 2013
Posted: December 27, 2013
Terminated: April 24, 2014
Recall Number: Z-0597-2014
Quantity: 352
Firm Location: Sunnyvale, CA
Official Source: View on FDA website ↗

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.

Distribution

Nationwide Distribution.

Lot / Code Info

Asante Catalog number:FG-4147-5, FG-4147T Unomedical Item number:87-110-2662; Lot numbers: 0230121 0230125 5025227.

Root Cause

Device Design

Action Taken

Asante sent urgent medical device recall notifications letters to distributors and customers on November 19, 2013 by US mail, return receipt requested.