FDA recall Z-0371-2020

Product

CORFLO* Percutaneous Endoscopic Gastrostomy (PEG) Kit, Labeled as CORFLO* PEG Kit with ENFit Connector. 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-0371-2020