TELEFLEX MEDICAL INC recalls RUSCH¿ POLARIS" Laryngoscope - Product Usage: intended to allow direct visualization of the laryngeal structure and is…

Recall date

February 18, 2021

Source

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

Recall number

Z-1294-2021

FDA classification

Class II

Brand / firm

TELEFLEX MEDICAL INC

Sold / distributed

Worldwide distribution - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI. The country of Canada.

Why it was recalled

Teleflex is voluntarily recalling the products referenced above due to customers reporting that the laryngoscope handles develop cracks and/or break at the hinge.

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

What was recalled

RUSCH¿ POLARIS" Laryngoscope - Product Usage: intended to allow direct visualization of the laryngeal structure and is used during tracheal intubation.