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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 Terminated on April 24, 2014
Recall Number Z-0594-2014
Recall Event ID 66895
Premarket Notification
510(K) Number
Product Classification Set, Administration, Intravascular - Product Code FPA
Product Asante 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/
Asante Solutions, Inc.
352 E Java Dr
Sunnyvale, California 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
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 834 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