Teleflex Medical: 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.

Recall number

Z-2367-2015

Recalling firm

Teleflex Medical

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.

Status

Terminated

Initiated

2015-06-01

Posted

2015-08-20

Terminated

2018-04-16

Reason

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

Root cause

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

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.

Lot, serial or model codes

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.

510(k) numbers

["K961977"]

PMA numbers

not on file

Product code

CBI

Firm FEI

3005747797

Firm city

Research Triangle Park

Firm state

NC

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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