Recall Z-2533-2020— TELEFLEX MEDICAL INC

Name: FDA recall Z-2533-2020
Creator: U.S. Food and Drug Administration
Published: 2020-05-29

Class II · Terminated

Class II FDA medical device recall by TELEFLEX MEDICAL INC, initiated 2020-05-29, terminated 2025-06-17. It names one FDA 510(k) clearance: K935842. 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.. Reason: 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..

Recalling firm: TELEFLEX MEDICAL INC
Classification: Class II
Status: Terminated
Initiated: 2020-05-29
Terminated: 2025-06-17
Firm location: Morrisville, NC, United States

510(k) clearances named in this recall

1 on FDA's record

K935842 — RUSCH LASERTUBUS/RUSCH LASER RESISTANT CUFFED WITH MURPHY EYERusch, Inc.·cleared 1995-05-23

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.