RecallRadar

FDA Device recall Z-2367-2015

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

On 2015-08-26 the FDA classified a Class I recall of 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 by Teleflex Medical, citing the double swivel connector may crack or separate on the endobronchial tube.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2367-2015
ClassificationClass I
Statusterminated
Initiated2015-06-01
Published2015-08-26
Last updated2026-09-13 11:53 UTC
CompanyTeleflex Medical
DistributionUS

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.

Reason

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

Identifiers

code_info
Product Code: 5-16028, Lot numbers: 01L1300279, 01A1400574, 73D1400255, 73F1400448, 73J1400537, 73A1500341 and 73C15004…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

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2367-2015%22

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