Recall Z-2969-2020— Avanos Medical, Inc.

Name: FDA recall Z-2969-2020
Creator: U.S. Food and Drug Administration
Published: 2020-07-29

Class II · Terminated

Class II FDA medical device recall by Avanos Medical, Inc., initiated 2020-07-29, terminated 2023-01-31. It names one FDA 510(k) clearance: K122653. Product: AVANOS MIC-KEY SF Gastrostomy Feeding Tube. Reason: Devices had cracked or detached from the feeding tube body.

Recalling firm: Avanos Medical, Inc.
Classification: Class II
Status: Terminated
Initiated: 2020-07-29
Terminated: 2023-01-31
Firm location: Alpharetta, GA, United States

510(k) clearances named in this recall

1 on FDA's record

K122653 — MIC-KEY SF LOW PROFILE GASTROSTOMY TUBE AND ACCESSORIESKimberly-Clark Corporation·cleared 2013-06-26

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

AVANOS MIC-KEY SF Gastrostomy Feeding Tube

Reason for recall

Devices had cracked or detached from the feeding tube body

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