TOPIC: Monoject Disposable Syringes by Cardinal Health: Class I Recall - Due to Incompatibilities with Syringe Pumps
AUDIENCE: Patient, Health Professional, Risk Manager
ISSUE: In June 2023, Cardinal Health began distributing Monoject syringes branded as “Cardinal Health Monoject syringes.” These new syringes differ from the previously branded “Covidien Monoject syringes” as they have different dimensions.
The affected Cardinal Health Monoject syringes should not be used with syringe pumps. The dimensional changes made to the affected Cardinal Health Monoject syringes when used with syringe pumps may result in pump performance issues such as overdose, underdose, delay in therapy, and delays in occlusion alarms.
Cardinal Health has received 15 reports of delayed therapy due to syringe infusion pumps not recognizing syringes, and 13 reports of inaccurate volume/rate dispensing, including some injuries. Cardinal Health has not received any reports of patient death.
For more information about this recall, click on the red button "Read Recall" below.
BACKGROUND:
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Cardinal Health Monoject disposable syringes are used to inject fluid into or withdraw fluids from the body. When used with syringe pumps, the Monoject disposable syringes are loaded with fluid or medications and placed into the pump.
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Syringe pumps deliver solutions such as fluids, medications, and blood products to patients.
RECOMMENDATIONS:
On September 20, 2023, Cardinal Health sent all affected customers an Urgent Medical Device Product Correction Letter.
The letter requested customers to:
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Review your inventory for the affected product codes and lots.
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Communicate with all personnel that utilize the Cardinal Health Monoject Luer-Lock Tip syringes (1, 6, 12, 20, 35 and 60 mL) that they should not be used with syringe infusion pumps.
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Post a copy of this notification in your storeroom where the product is stored.
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Notify any customers to whom you may have distributed/forwarded affected product to or will send the product on to about this medical device product correction and share a copy of this notice.
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Return the provided acknowledgment form via fax to 614-652-9648 or email to GMB-FieldCorrectiveAction@cardinalhealth.com, whether you have affected product or not.
- Customers in the U.S. with questions about this recall should contact the Cardinal Health market action team at 1-800-292-9332 or email GMB-FieldCorrectiveAction@cardinalhealth.com.
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