Recall Z-1032-2022— Avanos Medical, Inc.

Name: FDA recall Z-1032-2022
Creator: U.S. Food and Drug Administration
Published: 2022-03-21

Class I · Terminated

Class I FDA medical device recall by Avanos Medical, Inc., initiated 2022-03-21, terminated 2024-09-09. It names 2 FDA 510(k) clearances: K191340, K113351. Product: Avanos Cortrak 2 Enteral Access System (EAS). Reason: Product labeling is being modified. STOP using the Anonymous Account Mode feature of the CORTRAK 2 device immediately. CONFIRM placement of the NG/NI tube per institution protocol..

Recalling firm: Avanos Medical, Inc.
Classification: Class I
Status: Terminated
Initiated: 2022-03-21
Terminated: 2024-09-09
Firm location: Alpharetta, GA, United States

510(k) clearances named in this recall

2 on FDA's record

K191340 — CORTRAK* 2 Equilateral Enteral Access SystemAvanos Medical, Inc.·cleared 2019-06-04
K113351 — CORTRAK ENTERAL ACCESS DEVICECorpak Medsystems·cleared 2012-01-10

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

Avanos Cortrak 2 Enteral Access System (EAS)

Reason for recall

Product labeling is being modified. STOP using the Anonymous Account Mode feature of the CORTRAK 2 device immediately. CONFIRM placement of the NG/NI tube per institution protocol.

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