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U.S. Department of Health and Human Services

Class 2 Device Recall Asante Conset Infusion Set

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  Class 2 Device Recall Asante Conset Infusion Set see related information
Date Initiated by Firm November 19, 2013
Date Posted December 27, 2013
Recall Status1 Terminated 3 on April 24, 2014
Recall Number Z-0601-2014
Recall Event ID 66895
510(K)Number K120872  
Product Classification Set, administration, intravascular - Product Code FPA
Product Asante Conset Infusion Set with tubing & 9mm cannula packaged in 5-packs,singles,or inside a Combination Kit (FG-5249-4)
Distributed by Asante Solutions,
Sunnyvale, CA;
Manufactured by Convatec;
Lejre, Denmark.
Code Information Asante Catalog number:FG-4249-5, FG-4249T;  Unomedical Item number: 43-110-5269; Lot numbers:  0230129 5005804 5040412.
Recalling Firm/
Asante Solutions, Inc.
352 E Java Dr
Sunnyvale CA 94089-1328
For Additional Information Contact Edward J. Sinclair
Manufacturer 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.
FDA Determined
Cause 2
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 in Commerce 1085 kits
Distribution Nationwide Distribution.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FPA and Original Applicant = UNOMEDICAL A/S INFUSION DEVICES