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
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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.
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510(K) Database | 510(K)s with Product Code = FPA
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