Recalls & safety alerts
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Do Not Use Cardinal Health Monoject Syringes with Syringe Pumps and PCA Pumps
Recall date
Brand
Cardinal HealthLot code/Notes
On September 20, 2023, Cardinal Health initiated a recall for certain Cardinal Health Monoject single use Luer-lock tip syringes to not be used with syringe pumps. This recall is a correction, not a product removal. The FDA classified this as a Class I recall, the most serious type of recall.However, the FDA has concerns that the information provided by Cardinal Health has not sufficiently mitigated the risk of incompatibility when Cardinal Health Monoject syringes are used with other pumps, specifically PCA pumps. In addition, the FDA has concerns that the risk of incompatibility could apply to additional sizes of Cardinal Health Monoject syringes. The FDA is working with the manufacturer to address these questions.
Reason
The dimensional changes made to the Cardinal Health Monoject syringes, when used with syringe pumps or PCA pumps, may result in recognition, compatibility, and pump performance issues such as overdose, underdose, delay in therapy, and delays in occlusion alarms.