Recall Z-0370-2020— Avanos Medical, Inc.

Name: FDA recall Z-0370-2020
Creator: U.S. Food and Drug Administration
Published: 2019-10-08

Class II · Terminated

Class II FDA medical device recall by Avanos Medical, Inc., initiated 2019-10-08, terminated 2022-03-16. It names one FDA 510(k) clearance: K882867. Product: CORFLO* Percutaneous Endoscopic Gastrostomy (PEG) Kit, Labeled as CORFLO* PEG Kit. 2 units per case The devices could be branded as Halyard Health.. Reason: The connector piece to the PEG tube does not pass over the guidewire..

Recalling firm: Avanos Medical, Inc.
Classification: Class II
Status: Terminated
Initiated: 2019-10-08
Terminated: 2022-03-16
Firm location: Alpharetta, GA, United States

510(k) clearances named in this recall

1 on FDA's record

K882867 — CORPAK PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TUBECorpak Co.·cleared 1988-09-21

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* Percutaneous Endoscopic Gastrostomy (PEG) Kit, Labeled as CORFLO* PEG Kit. 2 units per case The devices could be branded as Halyard Health.

Reason for recall

The connector piece to the PEG tube does not pass over the guidewire.

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