The Recall Desk

FDA (Devices) recall action 84021

Avanos Medical, Inc. recalled 2 products on 2019-11-20

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2019-11-20
Critical
0
Units
—

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

States named across these recalls

1–2 of 2

  • HighFDA (Devices)··2019-11-20

    Avanos Medical Recalls CORFLO PEG Kits Due to Connector Defect

    Avanos Medical is recalling CORFLO PEG Kits because the connector piece does not pass over the guidewire. The recall affects 104 cases distributed to six US states and Great Britain.

    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.
    Category
    Distribution
    6 states
  • SevereFDA (Devices)··2019-11-20

    Avanos Medical Recalls CORFLO PEG Kits Due to Connector Defect

    Avanos Medical is recalling CORFLO PEG Kits because the connector piece does not pass over the guidewire. The recall affects 104 cases distributed to six US states and Great Britain.

    Product
    CORFLO* Percutaneous Endoscopic Gastrostomy (PEG) Kit, Labeled as CORFLO* PEG Kit. 2 units per case The devices could be branded as Halyard Health.
    Category
    Distribution
    6 states