Class 2 Device Recall Sure T

• Date Initiated by Firm: May 21, 2015
• Date Posted: June 19, 2015
• Recall Status: Terminated on January 23, 2017
• Recall Number: Z-1821-2015
• Recall Event ID: 71332
• 510(K)Number: K120395
• Product Classification: Set, administration, intravascular - Product Code FPA
• Product: Sure T, contact, contact detach, neria, neria detach, neria multi and thalaset; ; Used in combination with infusion pumps for continuous subcutaneous infusion of medication.
• Code Information: 210131, 212482, 213575, 213576, 214509, 214511, 216175, 216295, 216296, 218110, 218111, 218685, 219030, 219075, 220160, 220161, 220163, 223771, 224282, 224283, 224284, 224285, 224286, 226935, 226939, 226940, 227062, 227063, 227064, 227065, 227892, 227894, 229302, 230245, 231124, 231127, 231130, 232701, 232702, 233875, 656782, 656785, 657341, 657836, 657966, 667536, 669845, 4262911, 4263093, 4263094, 4263095, 4263098, 4263099, 4263100, 4263112, 4263113, 4263130, 4263131, 4263132, 4263170, 4263171, 4263172, 4263178, 4263179, 4263293, 4263240, 4263241, 4263307, 4263308, 4263328, 4263329, 4263372, 4263391, 4263393, 4263394, 4263400, 4263420, 4263421, 4263458, 4263474, 4263475, 4263476, 4263486, 4263517, 4263529, 4263551, 4263552, 4263571, 4263572, 4263580, 4263609, 4263624, 4263631, 4263665, 4263677, 4263678, 4263694, 4263695, 4263696, 4263716, 4263718, 4263719, 4263738, 4263750, 4263778, 5000119, 5000120, 5001718, 5003702, 5003920, 5003921, 5006040, 5006041, 5006567, 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• Recalling Firm/ Manufacturer: Unomedical As; Aholmvej 1 3 Osted; Roskilde Denmark
• Manufacturer Reason for Recall: Unomedical has found that in rare cases the steel needle can break during use, interrupting the delivery of medication including insulin.
• FDA Determined Cause: Nonconforming Material/Component
• Action: Each consignee was sent an "Urgent Field Safety Notice Regarding Steel Cannula Infusion Sets" on 5/21/2015 via Express Mail. This notification identified the affected product as well as the reason for the recall. It also contained instructions on how to use the product. Customers were to contact their health care provider if they suspected that a needle had broken off and remained under the skin. Diabetic patients were to monitor their blood sugar and non diabetic patients were to monitor symptoms which would indicate drug delivery had failed. Questions should be directed to the persons identified in the letter.
• Quantity in Commerce: 22,976,870 units
• Distribution: Worldwide Distribution -- US, including the states of CA, IL, MN, and PA; and, the countries of Australia, Bahrain, Belgium, Canada, China, Cypress, Denmark, Estonia, France, Germany, Greece, Hong Kong, Hungary, Israel, Italy, Kuwait, Lebanon, Malaysia, Maldives, Oman, Schweiz, South Africa, Spain, Sweden, Switzerland, Netherlands, Turkey, United Arab Emirates, and United Kingdom.
• Total Product Life Cycle: TPLC 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) Database: 510(K)s with Product Code = FPA and Original Applicant = UNOMEDICAL DEVICES S.A DE C.V