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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 Recall
Asante Comfort Infusion Set
see related information
Date Posted December 27, 2013
Recall Status1 Open
Recall Number Z-0596-2014
Recall Event ID 66895
Premarket Notification
510(K) Number
K120872 
Product Classification Set, Administration, Intravascular - Product Code FPA
Product Asante Comfort Infusion Set with 110cm tubing & 13mm cannula packaged in 5-packs,singles, or inside a Combination Kit (FG-5143-4). Manufactured for: Asante Solutions Sunnyvale, CA; Manufactured by: Unomedical Lejre, Denmark
Code Information Asante Catalog number: FG-4143-5, FG-4143T. Unomedical Item number: 87-110-2562 Lot numbers: 0230120; 0230124 5031108.
Recalling Firm/
Manufacturer
Asante Solutions, Inc.
352 E Java Dr
Sunnyvale, California 94089-1328
For Additional Information Contact Edward 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
DESIGN: 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 635 kits
Distribution Nationwide Distribution.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = FPA and Original Applicant = UNOMEDICAL A/S INFUSION DEVICES
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