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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. 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
- Affected units
- 267,217,860
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
Part of a larger recall action
This product is one of 3 recalled by Cardinal Health under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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