Recall Z-0565-2022— Avanos Medical, Inc.

Name: FDA recall Z-0565-2022
Creator: U.S. Food and Drug Administration
Published: 2021-12-22

Class II · Terminated

Class II FDA medical device recall by Avanos Medical, Inc., initiated 2021-12-22, terminated 2023-08-15. It names one FDA 510(k) clearance: K924065. Product: MIC* Percutaneous Endoscopic Gastrostomy PEG Kit - 20 Fr-PULL. Reason: The External Retention Bolster contained in the kit may be a larger diameter than the tube..

Recalling firm: Avanos Medical, Inc.
Classification: Class II
Status: Terminated
Initiated: 2021-12-22
Terminated: 2023-08-15
Firm location: Alpharetta, GA, United States

510(k) clearances named in this recall

1 on FDA's record

K924065 — MIC PEG TUBEMedical Innovations Corp.·cleared 1994-02-17

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

MIC* Percutaneous Endoscopic Gastrostomy PEG Kit - 20 Fr-PULL

Reason for recall

The External Retention Bolster contained in the kit may be a larger diameter than the tube.

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