—#137446

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.

FDA product code: CBI — Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
Device class: Class 2
Medical specialty: Anesthesiology
510(k) numbers: K961977
Affected lot / code info: 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.

Why it was recalled

The double swivel connector may crack or separate on the endobronchial tube.

Root cause (FDA determination)

Unknown/Undetermined by firm

Action the firm took

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.

Recalling firm

Firm: Teleflex Medical
Address: 2917 Weck Dr, Research Triangle Park, North Carolina 27709-0186

Distribution

Distribution pattern: Worldwide Distribution - US (nationwide) and the countries of: The Bahamas, Belgium, Argentina, Canada, China, India, Japan, South Korea, Mexico, New Zealand and Vietnam.

Timeline

Recall initiated: 2015-06-01
Posted by FDA: 2015-08-20
Terminated: 2018-04-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #137446. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.