The Recall Desk

FDA (Devices) recall action 73034

Pro-Dex Inc recalled 2 products on 2016-03-23

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
2016-03-23
Critical
0
Units
3,990

Why these products were recalled

The sterile battery may contain particulates within the sterile package.

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

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • ModerateFDA (Devices)··2016-03-23

    Pro-Dex Recalls Battery Packs for Surgical Screwdriver Due to Particulates

    Pro-Dex Inc is recalling 1,995 sterile battery packs for the KLS Martin Max Driver because they may contain particulates within the sterile package.

    Product
    Battery Pack KLS-SD-1000 Single Models: KLS-BP-001 Used to power the KLS Martin Max Driver (battery powdered surgical screwdriver).
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2016-03-23

    Pro-Dex Recalls Sterile Battery Packs for Surgical Screwdrivers

    Pro-Dex Inc is recalling sterile battery packs for the KLS Martin Max Driver because they may contain particulates within the sterile package.

    Product
    Battery Pack KLS-SD-1000 Case (40 ct) Models: KLS-BP-040 Used to power the KLS Martin Max Driver (battery powdered surgical screwdriver).
    Category
    Distribution
    1 state