||December 27, 2013
||Terminated on April 24, 2014
|Recall Event ID
Set, administration, intravascular -
||Asante Comfort Infusion Set with 110cm tubing & 13mm cannula packaged in 5-packs,singles, or inside a Combination Kit (FG-5143-4).
||Asante Catalog number: FG-4143-5, FG-4143T.
Unomedical Item number: 87-110-2562
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.
510(K)s with Product Code = FPA and Original Applicant = UNOMEDICAL A/S INFUSION DEVICES