The Recall Desk

FDA (Devices) recall action 88421

Cardinal Health recalled 3 products on 2021-09-01

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
2021-09-01
Critical
1
Units
801,653,580

Why these products were recalled

Potential for the plunger to draw back after the air has been expelled and reintroduce air back into the syringe.

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

1–3 of 3

  • CriticalFDA (Devices)··2021-09-01

    Monoject Sodium Chloride Flush Syringes Recalled for Air Embolism Risk

    Cardinal Health recalls 267 million Monoject 0.9% Sodium Chloride Flush Syringes due to a plunger defect that may reintroduce air into the syringe, posing a risk of air embolism during IV administration.

    Product
    Monoject 0.9% Sodium Chloride Flush Syringe, 3 mL Fill, STERILE, Product Code 8881570123 The proposed device is indicated for use in flushing compatible intravenous tubing systems and indwelling intravascular access devices.
    Category
    Distribution
    50 states
  • SevereFDA (Devices)··2021-09-01

    Monoject flush syringe recall: plunger may reintroduce air into IV lines

    Cardinal Health Monoject flush syringes may have a defect allowing the plunger to draw back and reintroduce air into the syringe. The FDA issued a Class I recall for over 267 million units distributed nationwide.

    Product
    Monoject 0.9% Sodium Chloride Flush Syringe, 10 mL Fill, STERILE, Product Code 8881570121 The proposed device is indicated for use in flushing compatible intravenous tubing systems and indwelling intravascular access devices.
    Category
    Distribution
    50 states
  • SevereFDA (Devices)··2021-09-01

    Sodium Chloride Flush Syringe Recalled Due to Plunger Malfunction Risk

    Cardinal Health is recalling Monoject 0.9% Sodium Chloride Flush Syringes because the plunger may draw back after use and reintroduce air into the syringe.

    Product
    Monoject 0.9% Sodium Chloride Flush Syringe, 5mL Fill, STERILE, Product Code 8881570125 The proposed device is indicated for use in flushing compatible intravenous tubing systems and indwelling intravascular access devices.
    Category
    Distribution
    50 states