Cardinal Health recalls Lubricated Intubating Stylet 6FR that is inserted into an endotracheal tube to facilitate intubation. This product is u…

Recall date

December 23, 2014

Source

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

Recall number

Z-1054-2015

FDA classification

Class II

Brand / firm

Cardinal Health

Sold / distributed

US: Nationwide (AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, PA, SC, TN, TX, UT, VA, WA, WI, WV, WY) + District of Columbia + Guam + US Army Facility in South Korea

Why it was recalled

A small piece of the stylet sheath has the potential to shear off upon removal of the stylet from the tracheal tube.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Lubricated Intubating Stylet 6FR that is inserted into an endotracheal tube to facilitate intubation. This product is used in surgical or medical emergency facilities. Primarily used on infants and pediatric patients.