Recall Z-1687-2023— Avanos Medical, Inc.

Name: FDA recall Z-1687-2023
Creator: U.S. Food and Drug Administration
Published: 2023-04-24

Class II · Terminated

Class II FDA medical device recall by Avanos Medical, Inc., initiated 2023-04-24, terminated 2024-08-02. It names one FDA 510(k) clearance: K162165. Product: SMMT ambIT Reusable Program - Luer Cass, Product Code: 220568. Reason: Some of the ambIT kits were potentially distributed without an air in-line filter..

Recalling firm: Avanos Medical, Inc.
Classification: Class II
Status: Terminated
Initiated: 2023-04-24
Terminated: 2024-08-02
Firm location: Alpharetta, GA, United States

510(k) clearances named in this recall

1 on FDA's record

K162165 — ambIT PCA*PIB, ambIT PIB, ambIT PIB*PCA, ambIT PIEB, and ambIT Programmable Intermittent PumpSummit Medical Products, Inc.·cleared 2017-08-29

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

SMMT ambIT Reusable Program - Luer Cass, Product Code: 220568

Reason for recall

Some of the ambIT kits were potentially distributed without an air in-line filter.

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