Drug Safety Alerts

Monoject™ Flush Prefilled Syringes (0.9% Sodium Chloride) Voluntary Recall

8/27/2021

On August 27, 2021, Cardinal Health issued a consumer-level recall of Monoject™ Flush Prefilled Syringes (0.9% Sodium Chloride). This recall was issued due to the potential for the plunger to draw back after the air has been expelled and reintroduce air back into the syringe.

This could be a health hazard or safety risk to patients who may be using product affected by this recall.

A complete list of the affected products and lot numbers is provided here.

Monoject™ Flush Prefilled Syringes (0.9% Sodium Chloride) contain preservative-free 0.9% Sodium Chloride Injection, USP in prefilled syringes of various sizes and fill volumes. They are disposable, single use only and are intended for use in flushing compatible intravenous tubing systems and indwelling intravascular access devices.

Cardinal Health received customer complaints where users were experiencing a plunger drawback with Monoject™ Flush Prefilled Syringes (0.9% Sodium Chloride). After the user expels the air bubble prior to use, the plunger may draw back and reintroduce air into the syringe.

If not aware of air being reintroduced into the syringe, it could inadvertently push air into the vascular system creating the potential for an air embolism. Injection of air into the vascular system can cause air embolism which can result in serious adverse health consequences or death.

Cardinal Health has not received any reports of patient harm or injury related to this issue.

At this time, Cardinal Health has ceased manufacturing and distributing these products.

CVS Caremark is in the process of contacting patients and prescribers to advise them of this recall. We are encouraging patients who are using Monoject™ Flush Prefilled Syringes (0.9% Sodium Chloride) to contact their prescriber.

CVS Caremark Response: Because of this action, CVS Caremark Mail Service Pharmacy is contacting patients and prescribers to advise them of this recall. We are encouraging patients who are taking Monoject™ Flush Prefilled Syringes (0.9% Sodium Chloride) to contact their prescriber.

For more information, please call Cardinal Health toll-free at 1-888-444-5440. You may also call the U.S. Food and Drug Administration (FDA) consumer inquiry line at 1-888-INFO-FDA (1-888-463-6332) or visit www.fda.gov.