The Recall Desk
SevereFDA (Devices)·Z-2286-2021·Announced 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.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This recall is classified FDA Class I, which establishes a minimum severity of 4 (Severe) per the rubric. Although the plunger malfunction poses potential risk, no deaths, hospitalizations, or injuries have been reported in the source text.

Plain-English summary

Monoject 0.9% Sodium Chloride Flush Syringes (Product Code 8881570125) manufactured by Cardinal Health are being recalled by the FDA due to a potential defect in the plunger mechanism. A total of 267,217,860 units have been distributed.

The problem: After air is expelled from the syringe, the plunger may draw back and reintroduce air into the syringe. These syringes are used for flushing compatible intravenous tubing systems and indwelling intravascular access devices.

This recall affects nationwide distribution across all US states and territories. Affected lot codes are: 20D0614, 21D0894, 20D0624, 20D0674, 20D0684, 20H1504, and 20H1514. Consumers and healthcare providers who have these products should discontinue use and contact Cardinal Health or their healthcare provider for instructions.

The recalled product

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.
Manufacturer
Cardinal Health
Hazard
  • air-reintroduction
  • plunger-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)

  • 20D0614 21D0894 20D0624 20D0674 20D0684 20H1504 20H1514

Distribution

Distributed nationwide across the United States.