Avanos Medical, Inc. recalls CORFLO* Percutaneous Endoscopic Gastrostomy (PEG) Kit, Labeled as CORFLO* PEG Kit. 2 units per case The devices could b…
- Recall date
- October 8, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0370-2020
- FDA classification
- Class II
- Brand / firm
- Avanos Medical, Inc.
- Sold / distributed
- Distribution to CT, IN, MD, NJ, PA, VA. International distribution to Great Britain.
Why it was recalled
The connector piece to the PEG tube does not pass over the guidewire.
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, Labeled as CORFLO* PEG Kit. 2 units per case The devices could be branded as Halyard Health.
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