Rusch Lasertubus/Rusch Laser Resistant Cuffed with Murphy Eye

• • Terminated Z-2533-2020 FDA Class II ·initiated 29 May 2020

  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.

• 5 recalls, same reason

  • Terminated Z-1686-2019 FDA Class II ·initiated 1 Apr 2019
  • Terminated Z-1684-2019 FDA Class II ·initiated 1 Apr 2019
  • Terminated Z-1685-2019 FDA Class II ·initiated 1 Apr 2019
  • Terminated Z-1682-2019 FDA Class II ·initiated 1 Apr 2019
  • Terminated Z-1683-2019 FDA Class II ·initiated 1 Apr 2019

  The firm received reports indicating that the laser guard foil partially separated and/or slightly detached at the edges.

• • Terminated Z-1851-2014 FDA Class II ·initiated 23 May 2014

  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.

510(k) Number

K935842 ↗

FDA Product Code

BTR

Device Class

Class II

Regulation

21 CFR Part 868.5730

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Rusch Safety Clear Uncuffed with Magill Tip

  Class II

  FDA 510(k) K925507 Active Cleared 2 Sep 1993

• Rusch Agt Pvc Pref Oral Trach Tube, Uncuf W/Mur Ey Open recall

  Class II

  FDA 510(k) K931166 Active Cleared 22 Jun 1993

• Rusch Tracheal Bronchial Y Stent

  Class II

  FDA 510(k) K953593 Active Cleared 13 Oct 1995

• Rusch Agt Pvc Pref Nasal Trach Tub/Uncuf W/Mur Eye Open recall

  Class II

  FDA 510(k) K931165 Active Cleared 22 Jun 1993

• Rusch Simplastic Foley Catheterization Set

  Class II

  FDA 510(k) K963993 Active Cleared 17 Dec 1996

• Rusch Mmg/O'neil Catheter Open recall

  Class II

  FDA 510(k) K010420 Active Cleared 9 May 2001

See all devices from Rusch, Inc. →