• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Asante Conset Infusion Set

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Asante Conset Infusion Setsee related information
Date Initiated by FirmNovember 19, 2013
Date PostedDecember 27, 2013
Recall Status1 Terminated 3 on April 24, 2014
Recall NumberZ-0600-2014
Recall Event ID 66895
510(K)NumberK120872 
Product Classification Set, administration, intravascular - Product Code FPA
ProductAsante Conset Infusion Set with 110cm tubing & 6mm cannula packaged in 5-packs, singles,or inside a Combination Kit (FG-5246-4) Distributed by Asante Solutions, Sunnyvale, CA; Manufactured by Convatec; Lejre, Denmark.
Code Information Asante Catalog number:FG-4246-5, FG-4246T; Unomedical Item number:43-110-5266; Lot numbers:  0230128 5005803 5030168.
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 Commerce454 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
-
-