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TELEFLEX MEDICAL INC recalls RUSCH¿ POLARIS" Laryngoscope - Product Usage: intended to allow direct visualization of the laryngeal structure and is u
Recalled March 31, 2021 · FDA recall Z-1294-2021 · TELEFLEX MEDICAL
Hazard
Teleflex is voluntarily recalling the products referenced above due to customers reporting that the laryngoscope handles develop cracks and/or break at the hinge. · FDA Class II
Units
157, 150 units (156,980 units in the US; 170 units OUS)
Sold at
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.
Description
Teleflex is voluntarily recalling the products referenced above due to customers reporting that the laryngoscope handles develop cracks and/or break at the hinge.
Product
RUSCH¿ POLARIS" Laryngoscope - Product Usage: intended to allow direct visualization of the laryngeal structure and is used during tracheal intubation.
Manufacturer(s)
TELEFLEX MEDICAL INC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →