Recall Z-1822-2020— Avanos Medical, Inc.

Name: FDA recall Z-1822-2020
Creator: U.S. Food and Drug Administration
Published: 2020-03-16

Class II · Terminated

Class II FDA medical device recall by Avanos Medical, Inc., initiated 2020-03-16, terminated 2023-08-31. It names one FDA 510(k) clearance: K882867. Product: CORFLO Percutaneous Endoscopic Gastrostomy (PEG)Kit. Reason: The CORFLO PEG tube may become blocked at the center of the adapter (occluded) potentially causing a procedure to delayed or aborted..

Recalling firm: Avanos Medical, Inc.
Classification: Class II
Status: Terminated
Initiated: 2020-03-16
Terminated: 2023-08-31
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

Reason for recall

The CORFLO PEG tube may become blocked at the center of the adapter (occluded) potentially causing a procedure to delayed or aborted.

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