Recall Z-1078-2015— Teleflex Medical

Name: FDA recall Z-1078-2015
Creator: U.S. Food and Drug Administration
Published: 2015-01-09

Class II · Terminated

Class II FDA medical device recall by Teleflex Medical, initiated 2015-01-09, terminated 2016-09-27. It names one FDA 510(k) clearance: K822082. Product: Hudson RCI, Sheridan, Preformed Tracheal Tubes, Cuffed and Uncuffed, Rx Only, Sterile, Teleflex Medical.. Reason: Labeling; The affected product packaging is incorrectly labeled as being a cuffed oral ET tube; The correct product labeling is uncuffed nasal ET tube..

Recalling firm: Teleflex Medical
Classification: Class II
Status: Terminated
Initiated: 2015-01-09
Terminated: 2016-09-27
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

Hudson RCI, Sheridan, Preformed Tracheal Tubes, Cuffed and Uncuffed, Rx Only, Sterile, Teleflex Medical.

Reason for recall

Labeling; The affected product packaging is incorrectly labeled as being a cuffed oral ET tube; The correct product labeling is uncuffed nasal ET tube.

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