PlainRecalls
FDA Devices Critical Class I Terminated

HUDSON RCI, Sheridan Sher-I-BRONCH, Endobronchial Tube (Right 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.

Reported: August 26, 2015 Initiated: June 1, 2015 #Z-2368-2015

Product Description

HUDSON RCI, Sheridan Sher-I-BRONCH, Endobronchial Tube (Right 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.

Details

Recalling Firm
Teleflex Medical
Units Affected
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.
Location
Research Triangle Park, NC

Frequently Asked Questions

What product was recalled?
HUDSON RCI, Sheridan Sher-I-BRONCH, Endobronchial Tube (Right 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.. Recalled by Teleflex Medical. Units affected: 188,195 total units.
Why was this product recalled?
The double swivel connector may crack or separate on the endobronchial tube.
Which agency issued this recall?
This recall was issued by the FDA Devices on August 26, 2015. Severity: Critical. Recall number: Z-2368-2015.