FDA-Device2019-11-20Class II
CORFLO* Percutaneous Endoscopic Gastrostomy (PEG) Kit, Labeled as CORFLO* PEG Kit. 2 units per case The devices could be branded as Halyard Health.
Avanos Medical, Inc.
Hazard
The connector piece to the PEG tube does not pass over the guidewire.
Sold states
Distribution to CT, IN, MD, NJ, PA, VA. International distribution to Great Britain.
Affected count
104 cases (208 units) total
Manufactured in
5405 Windward Pkwy, N/A, Alpharetta, GA, United States
Products
CORFLO* Percutaneous Endoscopic Gastrostomy (PEG) Kit, Labeled as CORFLO* PEG Kit. 2 units per case The devices could be branded as Halyard Health.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0370-2020Don't want to check this manually?
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