Teleflex Medical recalls HUDSON RCI, Sheridan, SHER-I-SWIV and SHER-I-SWIV/FO Double Swivel, Rx Only, Sterile. Used temporarily to make rigid a…

Recall date

June 1, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2370-2015

FDA classification

Class I

Brand / firm

Teleflex Medical

Sold / distributed

Worldwide Distribution - US (nationwide) and the countries of: The Bahamas, Belgium, Argentina, Canada, China, India, Japan, South Korea, Mexico, New Zealand and Vietnam.

Why it was recalled

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

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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.