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TELEFLEX MEDICAL INC recalls RUSCH LASERTUBE (Rubber), RES 102004, Sizes: a) I.D. mm 4,0, Product Code 102004-000040 b) I.D. mm 5,0, Product Code 1
Recalled July 15, 2020 · FDA recall Z-2533-2020 · TELEFLEX MEDICAL
Hazard
Teleflex is initiating a voluntary recall for the above-mentioned products due to reports indicating that the laser guard foil partially separated and/or slightly detached at the edges in the presence of moisture. · FDA Class II
Units
6014 devices
Sold at
US Nationwide distribution.
Description
Teleflex is initiating a voluntary recall for the above-mentioned products due to reports indicating that the laser guard foil partially separated and/or slightly detached at the edges in the presence of moisture.
Product
RUSCH LASERTUBE (Rubber), RES 102004, Sizes: a) I.D. mm 4,0, Product Code 102004-000040 b) I.D. mm 5,0, Product Code 102004-000050 c) I.D. mm 6,0, Product Code 102004-000060 d) I.D. mm 7,0, Product Code 102004-000070 e) I.D. mm 8,0, Product Code 102004-000080 Product Usage: Tracheal intubation during laser surgery in the laryngeal area. The tube is resistant to the following kinds of laser: A R+ laser / ND/YAG laser / CO2 lasers (continuous-wave or pulsed) with a wave length ranging from 0.488 ¿m to 10.6 ¿m.
Manufacturer(s)
TELEFLEX MEDICAL INC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →