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U.S. Department of Health and Human Services

Class 2 Device Recall Asante Comfort Infusion Set

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 Class 2 Device Recall Asante Comfort Infusion Setsee related information
Date Initiated by FirmNovember 19, 2013
Date PostedDecember 27, 2013
Recall Status1 Terminated 3 on April 24, 2014
Recall NumberZ-0594-2014
Recall Event ID 66895
510(K)NumberK120872 
Product Classification Set, administration, intravascular - Product Code FPA
ProductAsante 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
Code Information Asante Catalog number: FG-4123-5 FG-4123T Unomedical Item number: 87-060-2562; Lot numbers: 0230118 0230122 5036994 
Recalling Firm/
Manufacturer		 Asante Solutions, Inc.
352 E Java Dr
Sunnyvale CA 94089-1328
For Additional Information ContactEdward J. Sinclair
408-716-5600
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
ActionAsante sent urgent medical device recall notifications letters to distributors and customers on November 19, 2013 by US mail, return receipt requested.
Quantity in Commerce834 kits
DistributionNationwide Distribution.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = FPA
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