The Recall Desk
CriticalFDA (Devices)·Z-2285-2021·Announced 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.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

Our severity reasoning: This recall meets the Critical (5) classification criteria as an FDA Class I emergency recall. The defect poses a serious risk of air embolism, a potentially life-threatening condition if air is introduced into the bloodstream during intravenous administration.

Plain-English summary

Cardinal Health is recalling 267,217,860 Monoject 0.9% Sodium Chloride Flush Syringes (3 mL, Product Code 8881570123) nationwide. These sterile syringes are used to flush intravenous tubing and indwelling vascular access devices.

The recall was initiated because of a defect in the plunger mechanism. The plunger may draw back after air has been expelled, potentially reintroducing air back into the syringe. This defect creates a risk of air embolism if the affected syringe is subsequently used to flush IV lines, which could introduce air into the bloodstream.

The affected lot codes are 20I1524, 20D0694, and 20I1584, distributed across all U.S. states. Healthcare facilities and users who have received these products should stop using them immediately and contact Cardinal Health for return or disposal instructions. Patients who received potentially affected syringes should consult their healthcare provider.

The recalled product

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.
Manufacturer
Cardinal Health
Category
Medical Device — Syringes / IV Administration
Hazard
  • air-embolism
  • device-malfunction

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • 20I1524 20D0694 20I1584

Distribution

Distributed nationwide across the United States.

Related recalls

Same category