Recall Z-0540-2021— Avanos Medical, Inc.

Name: FDA recall Z-0540-2021
Creator: U.S. Food and Drug Administration
Published: 2020-10-16

Class II · Terminated

Class II FDA medical device recall by Avanos Medical, Inc., initiated 2020-10-16, terminated 2022-09-30. It names one FDA 510(k) clearance: K043044. Product: CORFLO NG/NI Pediatric Neonatal Feeding Tube w/ Anti-IV Connector. Reason: Detachment of the Male AIV Adaptor from the Y-Connector..

Recalling firm: Avanos Medical, Inc.
Classification: Class II
Status: Terminated
Initiated: 2020-10-16
Terminated: 2022-09-30
Firm location: Alpharetta, GA, United States

510(k) clearances named in this recall

1 on FDA's record

K043044 — ANTI-I.V. ENTERAL FEEDING SYSTEMViasys Medsystems·cleared 2005-05-06

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

CORFLO NG/NI Pediatric Neonatal Feeding Tube w/ Anti-IV Connector

Reason for recall

Detachment of the Male AIV Adaptor from the Y-Connector.

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