Recall Z-2946-2020— Smiths Medical ASD Inc.

Name: FDA recall Z-2946-2020
Creator: U.S. Food and Drug Administration
Published: 2020-08-28

Class II · Terminated

Class II FDA medical device recall by Smiths Medical ASD Inc., initiated 2020-08-28, terminated 2021-05-13. It names 2 FDA 510(k) clearances: K083641, K914088. Product: Bivona Mid-Range Aire-Cuf Adult Tracheostomy Tube This tube is intended to provide direct airway access for a tracheotomized patient for up to 29 days. It may be reprocessed up to 10 times for single patient use.. Reason: Label has the incorrect size for the tracheotomy tube..

Recalling firm: Smiths Medical ASD Inc.
Classification: Class II
Status: Terminated
Initiated: 2020-08-28
Terminated: 2021-05-13
Firm location: Minneapolis, MN, United States

510(k) clearances named in this recall

2 on FDA's record

K083641 — BIVONA TRACHEOSTOMY TUBESSmiths Medical Asd, Inc.·cleared 2009-02-23
K914088 — BIVONA AIRE-CUF(R) PEDIATRIC TRACHEOSTOMY TUBEBivona Medical Technologies·cleared 1991-10-23

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

Bivona Mid-Range Aire-Cuf Adult Tracheostomy Tube This tube is intended to provide direct airway access for a tracheotomized patient for up to 29 days. It may be reprocessed up to 10 times for single patient use.

Reason for recall

Label has the incorrect size for the tracheotomy tube.

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