Recall Z-2367-2015— Teleflex Medical

Name: FDA recall Z-2367-2015
Creator: U.S. Food and Drug Administration
Published: 2015-06-01

Class I · Terminated

Class I FDA medical device recall by Teleflex Medical, initiated 2015-06-01, terminated 2018-04-16. It names one FDA 510(k) clearance: K961977. 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..

Recalling firm: Teleflex Medical
Classification: Class I
Status: Terminated
Initiated: 2015-06-01
Terminated: 2018-04-16
Firm location: Research Triangle Park, NC, United States

510(k) clearances named in this recall

1 on FDA's record

K961977 — KENDALL SHER-I-BRONCH ENDOBROCHIAL TUBEKendall Healthcare Products Co. Div.Of Tyco Health·cleared 1996-07-31

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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 for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.