FDA-Device2015-08-26Class I
HUDSON RCI, Sheridan, SHER-I-SWIV and SHER-I-SWIV/FO Double Swivel, Rx Only, Sterile. Used temporarily to make rigid a flexible tracheal tube to aid its insertion into a patient.
Teleflex Medical
Hazard
The double swivel connector may crack or separate on the endobronchial tube.
Sold states
Worldwide Distribution - US (nationwide) and the countries of: The Bahamas, Belgium, Argentina, Canada, China, India, Japan, South Korea, Mexico, New Zealand and Vietnam.
Affected count
188,195 total units
Manufactured in
2917 Weck Dr, Research Triangle Park, NC, United States
Products
HUDSON RCI, Sheridan, SHER-I-SWIV and SHER-I-SWIV/FO Double Swivel, Rx Only, Sterile. Used temporarily to make rigid a flexible tracheal tube to aid its insertion into a patient.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2370-2015Don't want to check this manually?
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