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 10…

Recall date

May 29, 2020

Source

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

Recall number

Z-2533-2020

FDA classification

Class II

Brand / firm

TELEFLEX MEDICAL INC

Sold / distributed

US Nationwide distribution.

Why it was recalled

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.

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 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.