Recall Z-1177-2017— Teleflex Medical

Name: FDA recall Z-1177-2017
Creator: U.S. Food and Drug Administration
Published: 2016-10-18

Class II · Terminated

Class II FDA medical device recall by Teleflex Medical, initiated 2016-10-18, terminated 2017-08-25. It names one FDA 510(k) clearance: K822082. Product: Sheridan/CF, Cuffed Tracheal Tube, Catalog # 5-10114 and Sheridan/HVT Cuffed Tracheal Tube, Catalog # 5-10315 A tracheal tube is inserted into a patients mouth or nose for airway management. Reason: Labeling inconsistency - units labeled with a 7mm tube may contain a size 6.5mm tube, and units labeled 7.5mm tube may contain a size 5.5mm tube..

Recalling firm: Teleflex Medical
Classification: Class II
Status: Terminated
Initiated: 2016-10-18
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

Sheridan/CF, Cuffed Tracheal Tube, Catalog # 5-10114 and Sheridan/HVT Cuffed Tracheal Tube, Catalog # 5-10315 A tracheal tube is inserted into a patients mouth or nose for airway management

Reason for recall

Labeling inconsistency - units labeled with a 7mm tube may contain a size 6.5mm tube, and units labeled 7.5mm tube may contain a size 5.5mm tube.

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