The Recall Desk

FDA (Devices) recall action 70397

Halyard Health recalled 3 products on 2015-03-11

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
2015-03-11
Critical
0
Units
—

Why these products were recalled

Defect: A hole or crack was found which may cause air to leak.

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

States named across these recalls

1–3 of 3

  • HighFDA (Devices)··2015-03-11

    Halyard Health Recalls KimVent Closed Suction Systems Due to Air Leak Defect

    Halyard Health is recalling KimVent Closed Suction Systems for Adults because a hole or crack may cause air to leak. The recall affects 5 cases distributed to specific US states and Japan.

    Product
    KimVent Closed Suction System for Adults, Double Swivel Elbow, 14 Fr. Sterile, Distributed by Kimberly Clark Global Systems, LLC.
    Category
    Distribution
    11 states
  • HighFDA (Devices)··2015-03-11

    Halyard Health Recalls KimVent Closed Suction Systems Due to Defects

    Halyard Health is recalling KimVent Closed Suction Systems for Adults because a hole or crack was found that may cause air to leak.

    Product
    KimVent Closed Suction System for Adults, Double Swivel Elbow, 12 Fr., Sterile, Distributed by Kimberly Clark Global Systems, LLC.
    Category
    Distribution
    11 states
  • HighFDA (Devices)··2015-03-11

    Halyard Health Recalls KimVent Wet Pak Closed Suction Systems

    Halyard Health is recalling KimVent Wet Pak closed suction systems because a defect may cause air leaks.

    Product
    KimVent Wet Pak, Closed Suction System for Adults, Double Swivel Elbow, 14 Fr. Sterile, Distributed by Kimberly Clark Global Systems, LLC.
    Category
    Distribution
    11 states