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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 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
Recall Number Z-0595-2014
Classification Class II
Code Info Asante Catalog number: FG-4127-5, FG-4127T Unomedical Item number: 87-060-2662 Lot numbers: 0230119 0230123 5023420 5031106
Product Distributed Qty 246 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.
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