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U.S. Department of Health and Human Services

Enforcement Report - Week of January 8, 2014

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Product Detail

Product Description Asante Conset Infusion Set with 60cm tubing & 6mm cannula packaged in 5-packs,singles,or inside a Combination Kit (FG-5226-4) Distributed by Asante Solutions, Sunnyvale, CA; Manufactured by Convatec; Lejre, Denmark.
Recall Number Z-0598-2014
Classification Class II
Code Info Asante Catalog number: FG-4226-5, G-4147T; Unomedical Item number:43-060-5266; Lot numbers: 0230126 5005801 5030167.
Product Distributed Qty 1392 kits
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.

Event Detail

Event Id 66895
Product Type Devices
Status Ongoing
Recalling Firm Asante Solutions, Inc.
City Sunnyvale
State CA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-11-19
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide Distribution.