The Recall Desk

FDA (Devices) recall action 76465

CORPAK MedSystems, Inc. recalled 3 products on 2017-05-31

The FDA (Devices) publishes a recall like this one as 3 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 3 pages.

Products
3
Announced
2017-05-31
Critical
0
Units
—

Why these products were recalled

Firm is initiating voluntary correction of CORFLO PEG with ENFit. Barb connector (stem) of the adapter may break unexpectedly when exposed to stress.

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

States named across these recalls

1–3 of 3

  • HighFDA (Devices)··2017-05-31

    CORPAK CORFLO PEG Kit Recall Due to Potential Connector Breakage

    CORPAK MedSystems is voluntarily recalling CORFLO PEG Kits because the ENFit connector stem may break unexpectedly under stress.

    Product
    CORFLO PEG Kit, Pull 16FR. Product Usage: CORFLO PEG Tubes are intended for delivery of enteral nutrition, water and medications into the stomach. The PEG adapter is the connection point between the tubing and the feeding set/syringe. The adapter is designed as a replaceabl
    Category
    Distribution
    3 states
  • HighFDA (Devices)··2017-05-31

    CORPAK CORFLO PEG Adaptor Repair Kit Recalled for Connector Breakage

    CORPAK MedSystems is voluntarily recalling CORFLO PEG Adaptor Repair Kits because the barb connector may break unexpectedly when exposed to stress.

    Product
    CORFLO, PEG Adaptor Repair Kit with ENFit Connectors, Size: 12FR (4mm); Product Usage: CORFLO PEG Tubes are intended for delivery of enteral nutrition, water and medications into the stomach. The PEG adapter is the connection point between the tubing and the feeding set/syri
    Category
    Distribution
    3 states
  • HighFDA (Devices)··2017-05-31

    CORPAK Recalls CORFLO PEG Adaptor Repair Kits Due to Breakage Risk

    CORPAK MedSystems is voluntarily recalling CORFLO PEG Adaptor Repair Kits because the barb connector may break under stress.

    Product
    CORFLO, PEG Adaptor Repair Kit with ENFit Connectors, Size: 16FR; Product Usage: CORFLO PEG Tubes are intended for delivery of enteral nutrition, water and medications into the stomach. The PEG adapter is the connection point between the tubing and the feeding set/syringe. T
    Category
    Distribution
    3 states