Recall Z-1684-2019— Teleflex Medical

Name: FDA recall Z-1684-2019
Creator: U.S. Food and Drug Administration
Published: 2019-04-01

Class II · Terminated

Class II FDA medical device recall by Teleflex Medical, initiated 2019-04-01, terminated 2025-06-03. It names one FDA 510(k) clearance: K935842. Product: RUSCH LASERTUBE (Rubber), Order No. : 102004-000060, REF 102004, SIZE I.D. mm 6,0. Reason: The firm received reports indicating that the laser guard foil partially separated and/or slightly detached at the edges..

Recalling firm: Teleflex Medical
Classification: Class II
Status: Terminated
Initiated: 2019-04-01
Terminated: 2025-06-03
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), Order No. : 102004-000060, REF 102004, SIZE I.D. mm 6,0

Reason for recall

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

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