Recall Z-1851-2014— Teleflex Medical

Name: FDA recall Z-1851-2014
Creator: U.S. Food and Drug Administration
Published: 2014-05-23

Class II · Terminated

Class II FDA medical device recall by Teleflex Medical, initiated 2014-05-23, terminated 2016-01-13. It names one FDA 510(k) clearance: K935842. Product: RUSCH, LaserTube (Rubber), Laser Resistant Tracheal Tube, cuffed, Teleflex Medical, Willy-Rusch, GmbH. A tracheal tube is a device inserted into a patient's trachea via the nose or mouth and used to maintain an open airway.. Reason: Although the Natural Rubber Latex caution symbol is clearly displayed on the product label, the accompanying caution statement "Caution: This product contains Natural Rubber Latex which may cause Allergic Reactions" was not printed on the product label..

Recalling firm: Teleflex Medical
Classification: Class II
Status: Terminated
Initiated: 2014-05-23
Terminated: 2016-01-13
Firm location: Research Triangle Park, 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), Laser Resistant Tracheal Tube, cuffed, Teleflex Medical, Willy-Rusch, GmbH. A tracheal tube is a device inserted into a patient's trachea via the nose or mouth and used to maintain an open airway.

Reason for recall

Although the Natural Rubber Latex caution symbol is clearly displayed on the product label, the accompanying caution statement "Caution: This product contains Natural Rubber Latex which may cause Allergic Reactions" was not printed on the product label.

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