FDA recall Z-0370-2020

Avanos Medical, Inc. · Class II · device

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 for recall

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

Distribution

Distribution to CT, IN, MD, NJ, PA, VA. International distribution to Great Britain.

Key facts

Status
Terminated
Initiation date
2019-10-08
Report date
2019-11-20
Termination date
2022-03-16
Voluntary/Mandated
Voluntary: Firm initiated
Location
Alpharetta, GA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0370-2020