Recall Z-0177-2022— Smiths Medical ASD Inc.

Name: FDA recall Z-0177-2022
Creator: U.S. Food and Drug Administration
Published: 2021-08-09

Class II · Terminated

Class II FDA medical device recall by Smiths Medical ASD Inc., initiated 2021-08-09, terminated 2023-10-13. It names one FDA 510(k) clearance: K792035. Product: Bivona Aire-Cuf Endotracheal Tube. Reason: Inadequate pouch seal leading to a compromised sterile barrier on products with a shaft length of 325mm..

Recalling firm: Smiths Medical ASD Inc.
Classification: Class II
Status: Terminated
Initiated: 2021-08-09
Terminated: 2023-10-13
Firm location: Minneapolis, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K792035 — FOME-CUF-WIRE RE-ENFORCED, AIRE-CUF WIREBivona Medical Technologies·cleared 1979-10-26

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 Aire-Cuf Endotracheal Tube

Reason for recall

Inadequate pouch seal leading to a compromised sterile barrier on products with a shaft length of 325mm.

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