Recall Z-2415-2015— Teleflex, Inc.

Name: FDA recall Z-2415-2015
Creator: U.S. Food and Drug Administration
Published: 2014-11-21

Class II · Terminated

Class II FDA medical device recall by Teleflex, Inc., initiated 2014-11-21, terminated 2017-08-15. It names one FDA 510(k) clearance: K951091. Product: Bronchial Double Lumen Tube Set (Left), Extra Length, Sterile. Reason: Customer complaints reporting that the cobb connector detached from the main connector prior to use..

Recalling firm: Teleflex, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-11-21
Terminated: 2017-08-15
Firm location: Wayne, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K951091 — RUSCH ENDOBRONCHIAL TUBE SETSRusch Intl.·cleared 1995-06-08

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

Bronchial Double Lumen Tube Set (Left), Extra Length, Sterile

Reason for recall

Customer complaints reporting that the cobb connector detached from the main connector prior to use.

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