||December 27, 2013
||Terminated on April 24, 2014
|Recall Event ID
Set, administration, intravascular -
||Asante Conset Infusion Set with 60cm tubing & 6mm cannula packaged in 5-packs,singles,or inside a Combination Kit (FG-5226-4)
Distributed by Asante Solutions,
Manufactured by Convatec;
||Asante Catalog number: FG-4226-5, G-4147T;
Unomedical Item number:43-060-5266;
Asante Solutions, Inc.
352 E Java Dr
|For Additional Information Contact
||Edward J. Sinclair
|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.
||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
|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.