Recall Z-1732-2019— Smiths Medical ASD Inc.

Name: FDA recall Z-1732-2019
Creator: U.S. Food and Drug Administration
Published: 2019-02-11

Class II · Terminated

Class II FDA medical device recall by Smiths Medical ASD Inc., initiated 2019-02-11, terminated 2020-11-02. It names one FDA 510(k) clearance: K030381. Product: Portex Blue Line Ultra Tracheostomy Tube Inner Cannula. One cannula comes inside a package which is labeled in part, Product Usage: The Portex Blue Line Ultra¿ Tracheostomy Tubes are indicated for airway maintenance of tracheostomized patients.. Reason: Packaged with an incorrect size inner cannula..

Recalling firm: Smiths Medical ASD Inc.
Classification: Class II
Status: Terminated
Initiated: 2019-02-11
Terminated: 2020-11-02
Firm location: Minneapolis, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K030381 — PORTEX BLUE LINE ULTRA TRACHEOSTOMY TUBE (CUFFED) WITH REUSABLE INNER CANNULAPortex , Ltd.·cleared 2003-08-27

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

Portex Blue Line Ultra Tracheostomy Tube Inner Cannula. One cannula comes inside a package which is labeled in part, Product Usage: The Portex Blue Line Ultra¿ Tracheostomy Tubes are indicated for airway maintenance of tracheostomized patients.

Reason for recall

Packaged with an incorrect size inner cannula.

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