Recall Z-1938-2016— Teleflex Medical

Name: FDA recall Z-1938-2016
Creator: U.S. Food and Drug Administration
Published: 2016-05-05

Class II · Terminated

Class II FDA medical device recall by Teleflex Medical, initiated 2016-05-05, terminated 2017-08-25. It names one FDA 510(k) clearance: K822082. Product: Sterile Sheridan/HVT Cuffed, Murphy Eye, Tracheal Tube, Ref: V5-10314, ID: 7.0 mm, Rx Only, Manufactured by: Teleflex Incorporated. A tracheal tube is inserted into a patients mouth or nose for airway management.. Reason: The labeling of some units indicates that it contains a size 7mm tracheal tube, but may contain a size 7.5mm tracheal tube..

Recalling firm: Teleflex Medical
Classification: Class II
Status: Terminated
Initiated: 2016-05-05
Terminated: 2017-08-25
Firm location: Research Triangle Park, NC, United States

510(k) clearances named in this recall

1 on FDA's record

K822082 — SHERIDAN/HVT,CF, UNCUFFEDSheridan Catheter Corp.·cleared 1982-08-10

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

Sterile Sheridan/HVT Cuffed, Murphy Eye, Tracheal Tube, Ref: V5-10314, ID: 7.0 mm, Rx Only, Manufactured by: Teleflex Incorporated. A tracheal tube is inserted into a patients mouth or nose for airway management.

Reason for recall

The labeling of some units indicates that it contains a size 7mm tracheal tube, but may contain a size 7.5mm tracheal tube.

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