Recall Z-2485-2020— Smiths Medical ASD Inc.

Name: FDA recall Z-2485-2020
Creator: U.S. Food and Drug Administration
Published: 2020-05-26

Class II · Terminated

Class II FDA medical device recall by Smiths Medical ASD Inc., initiated 2020-05-26, terminated 2021-05-05. It names one FDA 510(k) clearance: K081440. Product: Pediatric Adjustable Flange Tracheostomy Tube Cuffless. Reason: One lot of 3.0mm Bivona Cuffless Adjustable Neck Flange Hyperflex Pediatric Tracheostomy Tubes was packaged with a 3.5mm ID adjustable neck flange plate..

Recalling firm: Smiths Medical ASD Inc.
Classification: Class II
Status: Terminated
Initiated: 2020-05-26
Terminated: 2021-05-05
Firm location: Minneapolis, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K081440 — BIVONA ADJUSTABLE AND FIXED NECKFLANGE HYPERFLEX TRACHEOSTOMY TUBESSmiths Medical Asd, Inc.·cleared 2008-09-12

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

Pediatric Adjustable Flange Tracheostomy Tube Cuffless

Reason for recall

One lot of 3.0mm Bivona Cuffless Adjustable Neck Flange Hyperflex Pediatric Tracheostomy Tubes was packaged with a 3.5mm ID adjustable neck flange plate.

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