Agency classClass IOur severity:Severe FDA (Devices)·Z-2284-2021·Announced 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.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The FDA classified this device recall as Class I, establishing a minimum Severe (4) rating per the recall rubric. Although no deaths or serious injuries have been reported, the potential for air reintroduction into intravenous systems presents a known patient safety hazard affecting over 267 million units distributed nationwide.

Plain-English summary

Cardinal Health's Monoject 0.9% Sodium Chloride Flush Syringe is a sterile medical device indicated for flushing intravenous tubing systems and indwelling intravascular access devices. The device is now the subject of a recall due to a potential defect in the plunger mechanism.

The defect involves the plunger potentially drawing back after air has been expelled from the syringe, which can reintroduce air back into the syringe. When these syringes are subsequently used to flush intravenous lines, the reintroduced air could be delivered into the IV system.

The FDA has classified this as a Class I recall, its most serious classification, affecting approximately 267 million units with product code 8881570121. The affected devices were distributed nationwide across all U.S. states and territories. Multiple lot codes have been identified in the FDA recall notice.

Healthcare facilities and consumers should immediately discontinue use of affected syringes. Contact Cardinal Health or the FDA with questions about this recall. If IV therapy was administered using potentially affected devices, consult your healthcare provider for appropriate follow-up.

The recalled product

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.
Manufacturer: Cardinal Health
Category: Medical Device — IV infusion / flush syringe
Hazard: air-reintroduction
device-malfunction
Affected units: 267,217,860

Distribution

Distributed nationwide across the United States.

The notice also names 50 states specifically:

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.

See all 3 products in this recall →

Same manufacturer · Cardinal Health

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Same hazard · air reintroduction