The Recall Desk

FDA (Devices) recall action 77686

Cardinal Health 200, LLC recalled 2 products on 2017-08-02

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
2017-08-02
Critical
0
Units
2,119

Why these products were recalled

Outer label of some units of product number/lot number 8482, Lot 16LFS235 and product number/lot number 9414, Lot 16LUS317 do not match the drape packaged inside.

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)··2017-08-02

    Cardinal Health Recalls Mislabeled Sterile Surgical Drapes

    Cardinal Health is recalling specific lots of sterile surgical drapes because the outer labels do not match the packaged product inside.

    Product
    Converters(R) Under Buttocks Drape with Fluid Control Pouch II, REF 8482, STERILE R, Qty. 1, Cardinal Health, Waukegan, IL A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as…
    Category
    Distribution
    1 state
  • ModerateFDA (Devices)··2017-08-02

    Cardinal Health Recalls Tiburon Arthroscopy Drapes Due to Labeling Mismatch

    Cardinal Health is recalling specific lots of Tiburon Arthroscopy Drapes because the outer labels do not match the packaged product.

    Product
    Converters(R) Tiburon(R) Arthroscopy Drape, REF 9414, STERILE EO, Qty. 1, Cardinal Health, Waukegan, IL A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of…
    Category
    Distribution
    1 state