Date Initiated by Firm |
November 19, 2013 |
Date Posted |
December 27, 2013 |
Recall Status1 |
Terminated 3 on April 24, 2014 |
Recall Number |
Z-0596-2014 |
Recall Event ID |
66895 |
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 CA 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 |
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
|
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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) Database |
510(K)s with Product Code = FPA and Original Applicant = UNOMEDICAL A/S INFUSION DEVICES
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