Medical device recalls Moderate risk

Avanos Medical, Inc. recalls CORFLO Percutaneous Endoscopic Gastrostomy (PEG)Kit

Recall date
March 16, 2020
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1822-2020
FDA classification
Class II
Brand / firm
Avanos Medical, Inc.
Sold / distributed
Worldwide and US Nationwide Distribution: AZ, CA, CT, FL, GA, IA, ID, IL, LA, MO, MN, MD, NY, NM, NV, NJ, OR, OK, OH, RI, TN, TX, WA, WI, ***Foreign: Distributed to Australia, Belgium, Canada, France, Germany, Ireland, Italy, Netherlands, Romania, United Arab Emirates, United Kingdom

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

CORFLO Percutaneous Endoscopic Gastrostomy (PEG)Kit

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