| Class 1 Device Recall HUDSON RCI | |
Date Initiated by Firm | June 01, 2015 |
Date Posted | August 20, 2015 |
Recall Status1 |
Terminated 3 on April 16, 2018 |
Recall Number | Z-2367-2015 |
Recall Event ID |
71360 |
510(K)Number | K961977 |
Product Classification |
Tube, tracheal/bronchial, differential ventilation (w/wo connector) - Product Code CBI
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Product | HUDSON RCI, Sheridan Sher-I-BRONCH, Endobronchial Tube (Left sided), Sizes: 28 Fr., 35 Fr., 37 Fr., 39 Fr. and 41 Fr., Rx Only, Sterile.
Intended for use in thoracic surgery, bronchospirometry, for the administration of bronchial anesthesia and other uses commonly requiring bronchial intubation. |
Code Information |
Product Code: 5-16028, Lot numbers: 01L1300279, 01A1400574, 73D1400255, 73F1400448, 73J1400537, 73A1500341 and 73C1500431; Product Code: 5-16035, Lot numbers: 01J1300471, 01J1300472, 01K1300050, 01K1300073, 01K1300578, 01L1300382, 01L1300383, 01L1300557, 01M1300073, 01M1300312, 01A1400226, 01A1400432, 01B1400083, 01B1400356, 01B1400357, 01C1400260, 73D1400097, 73E1400504, 73F1400449, 73G1400387, 73G1400597, 73H1400033, 73H1400332, 73J1400259, 73J1400260, 73J1400261, 73K1400130, 73K1400131, 73K1400132, 73K1400225, 73K1400226, 73K1400227, 73L1400236, 73L1400382, 73L1400383, 73L1400384, 73L1400489, 73L1400583, 73L1400608, 73A1500481, 73A1500482, 73B1500077, 73B1500078, 73B1500353, 73B1500529, 73B1500530, 73B1500531, 73C1500256, 73C1500257, 73C1500581 and 73D1500099; Product Code: 5-16037, Lot numbers: 01K1300143, 01K1300144, 01K1300346, 01K1300347, 01K1300579, 01L1300081, 01L1300280, 01L1300281, 01L1300384, 01L1300558, 01M1300074, 01M1300117, 01M1300213, 01M1300313, 01A1400121, 01A1400194, 01A1400433, 01A1400575, 01B1400084, 01B1400115, 01B1400242, 01C1400087, 01C1400088, 01C1400285, 73D1400256, 73D1400627, 73E1400270, 73E1400366, 73F1400189, 73G1400053, 73G1400176, 73H1400034, 73H1400161, 73H140033, 73H1400442, 73J1400538, 73J1400547, 73K1400341, 73K1400342, 73K1400343, 73K1400462, 73L1400098, 73L1400234, 73L1400235, 73L1400584, 73L1400609, 73M1400071, 73M1400072, 73M1400073, 73M1400192, 73M1400193, 73A1500342, 73A1500343, 73A1500344, 73A1500590, 73A1500589, 73B1500076, 73B1500532, 73C1500110, 73C1500111, 73C1500531, 73C1500532, 73C1500582, 73D1500096, 73D1500097 and 73D1500098; Product Code: 5-16039, Lot numbers: 01K1300469, 01L1300082, 01L1300083, 01L1300559, 01M1300214, 01A1400227, 01A1400576, 01B1400243, 01B1400478, 73C1400067, 73D1400340, 73E1400114, 73F1400353, 73G1400256, 73G1400377, 73J1400398, 73J1400408, 73K1400463, 73L1400196, 73L1400097, 73M1400194, 73A1500483, 73A1500484, 73A1500591, 73A1500592, 73C1500112, 73C1500113, 73C1500258, 73C1500259, 01L1300385, 01A1400122, 01C1400261, 73E1400115, 73G1400388, 73J1400399, 73A1500204, 73B1500533, 73C1500583, 01L1300155 and 01A1400453; Product Code: 5-16041, Lot numbers: 73B1500256, 01C1400406, 73D1400497, 73F1400095, 73J1400116, 73J1400133, 73K1400464 and 73K1400465. |
Recalling Firm/ Manufacturer |
Teleflex Medical 2917 Weck Dr Research Triangle Park NC 27709-0186
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For Additional Information Contact | Tara Torres 610-378-0131 |
Manufacturer Reason for Recall | The double swivel connector may crack or separate on the endobronchial tube. |
FDA Determined Cause 2 | Unknown/Undetermined by firm |
Action | Teleflex Medical sent an Urgent Medical Device Recall Notification letter dated June 1, 2015 to their customers. The letter identified the affected product, problem and actions to be taken. Customers were directed to contact any customers who had received the product included within the scope of this recall. Customers were directed to immediately discontinue use and quarantine any products with the referenced catalog numbers and lot numbers listed in the notification. Additionally, customers were asked to return any affected product together with a completed Recall Acknowledgement Form, for consolidation and return to Teleflex Medical. For questions contact your local sales representative or Customer Service at 1-866-246-6990. |
Quantity in Commerce | 188,195 total units |
Distribution | Worldwide Distribution - US (nationwide) and the countries of: The Bahamas, Belgium, Argentina, Canada, China, India, Japan, South Korea, Mexico, New Zealand and Vietnam. |
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 = CBI
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