The Recall Desk

FDA (Devices) recall action 80289

Cardinal Health 200, LLC recalled 4 products on 2018-07-25

The FDA (Devices) publishes a recall like this one as 4 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 4 pages.

Products
4
Announced
2018-07-25
Critical
0
Units
35,712

Why these products were recalled

A defect in the seal of the Gatorade pouch contained in kits caused the pouch to leak within a limited portion of the kit.

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

1–4 of 4

  • ModerateFDA (Devices)··2018-07-25

    Cardinal Health Recalls Presource PBDS Kits Due to Leaking Gatorade Pouches

    Cardinal Health is recalling 8,928 Presource PBDS kits because a defect in the Gatorade pouch seal caused the pouch to leak within the kit.

    Product
    Presource PBDS, Kit, No Spiro Diabetes. Kit includes a exerciser volumetric 5000 ML device, two items of cloth, skin prep 2% CHG, a packet of 4 chlorhexidine gluconate antiseptic cloths, and Gatorade pouches. Product Usage: The kit is provided to a patient pre-surgery, as pa
    Category
    Distribution
    1 state
  • ModerateFDA (Devices)··2018-07-25

    Cardinal Health Recalls Presource PBDS Kits Due to Gatorade Pouch Seal Defect

    Cardinal Health is recalling 8,928 Presource PBDS kits because a defect in the Gatorade pouch seal caused the pouch to leak within the kit.

    Product
    Presource PBDS, Kit, Common. Kit includes a exerciser volumetric 5000 ML device, two items of cloth, skin prep 2% CHG, a packet of 4 chlorhexidine gluconate antiseptic cloths, and Gatorade pouches. Product Usage: The kit is provided to a patient pre-surgery, as part of the
    Category
    Distribution
    1 state
  • ModerateFDA (Devices)··2018-07-25

    Cardinal Health Recalls Presource PBDS Kits Due to Leaking Gatorade Pouches

    Cardinal Health is recalling 8,928 Presource PBDS kits because a defect in the Gatorade pouch seal caused the pouch to leak within the kit.

    Product
    Presource PBDS, Kit, Common Diabetes. Kit includes a exerciser volumetric 5000 ML device, two items of cloth, skin prep 2% CHG, a packet of 4 chlorhexidine gluconate antiseptic cloths, and Gatorade pouches. Product Usage: The kit is provided to a patient pre-surgery, as part
    Category
    Distribution
    1 state
  • ModerateFDA (Devices)··2018-07-25

    Cardinal Health Recalls Presource PBDS Kits Due to Leaking Gatorade Pouches

    Cardinal Health is recalling Presource PBDS kits because a defect in the Gatorade pouch seal caused the pouch to leak within the kit.

    Product
    Presource PBDS, Kit, No Spiro. Kit includes a exerciser volumetric 5000 ML device, two items of cloth, skin prep 2% CHG, a packet of 4 chlorhexidine gluconate antiseptic cloths, and Gatorade pouches. Product Usage: The kit is provided to a patient pre-surgery, as part of the
    Category
    Distribution
    1 state