FDA-Device2021-03-31Class II
RUSCH¿ POLARIS" Laryngoscope - Product Usage: intended to allow direct visualization of the laryngeal structure and is used during tracheal intubation.
TELEFLEX MEDICAL INC
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.
Sold states
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.
Affected count
157, 150 units (156,980 units in the US; 170 units OUS)
Manufactured in
3015 Carrington Mill Blvd, N/A, Morrisville, NC, United States
Products
RUSCH¿ POLARIS" Laryngoscope - Product Usage: intended to allow direct visualization of the laryngeal structure and is used during tracheal intubation.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1294-2021Don't want to check this manually?
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