Cardinal Health Monoject Recall Expanded to Impact Nearly 28M Syringes

The FDA has declared a February product correction as a Class I Monoject syringe recall, following numerous reports of problems with the new syringes’ dimensions.

Cardinal Health is pulling 28 million Monoject syringes from the market, following numerous reports of problems when used with various drug pumps, which may cause the device to malfunction and result in an overdose, underdose, or delay in therapy.

The U.S. Food and Drug Administration (FDA) announced the Cardinal Health Monoject syringe recall on March 7, warning that manufacturing changes to the syringes’ dimensions could affect performance of the pump, impacting both luer-lock and enteral syringe versions.

Cardinal Health Monoject luer-lock disposable syringes are used to inject or withdraw fluids and medications, and are designed to be used with a syringe pump or patient-controlled analgesic (PCA) pump. The Monoject enteral syringes deliver fluids, medications, and feeding nutrition to a patient’s enteral tube, or feeding tube, and are designed to be used with enteral syringe feeding pumps.

Recalled Monoject Syringes May Fail

Certain drug pumps and other devices have pre-programmed syringe dimensions that are used to determine how much medication is in the syringe, based on information about the brand from its compatible syringe library. However, agency officials warned that the dimensions of Cardinal Health Monoject syringes underwent a modification in June 2023, which coincided with the company’s rebranding of Monoject syringes under the “Covidien” brand, and a shift to a different product manufacturer.

Due to these alterations in dimensions and manufacturing, medical pumps may fail to recognize the syringes, leading to potential issues such as refusal to operate, medication overdosing or underdosing, delays in therapy, occlusion alarm delays, or feeding delays.

Monoject Syringe Warnings

Cardinal Health initially issued a Monoject syringe product correction in September 2023 due to the size problems, which affected more than 32 million syringes. Then in November 2023, the FDA issued a Cardinal Health Monoject Syringe warning, urging consumers and health care professionals to avoid using the new Monoject syringes with PCA pumps, due to a risk that they may not fit and could be incompatible with the devices.

Officials issued the warning following at least 15 complaints of infusion pumps failing to recognize the syringes, resulting in delayed therapy. The FDA also received at least 13 other complaints involving inaccurate medication dispensing, which resulted in an undisclosed number of injuries.

An Alaris infusion pump recall was issued in December 2023, after at least 13 injuries were reported in relation to the incompatibility problems. The pumps were most commonly used with Monoject syringes, and used pre-programmed syringe dimensions that determined how much medication was in the syringe.

Cardinal health Monoject Syringe Recall

This latest recall comes on the heels of a Cardinal Health urgent medical device product removal letter issued on February 2, concerning the sterile enteral syringes and the luer-lock syringes.

At that time, customers were urged to review their inventory for the affected product codes and lots, refrain from using them, communicate with all personnel who have used the affected products, notify any customers who may have received the distributed products, remove and quarantine all affected products, and complete and return the acknowledgement form included in the letter. However, according to the FDA announcement on March 7, these actions have been categorized as a Class I recall, indicating that the agency believes the problems can result in severe injury and death.

The recall affects 26,973,040 Luer Lock syringes distributed nationwide between June 1 2023 and August 31, 2023; and 701,678 Enteral syringes distributed between September 1, 2023 to October 10, 2023. Consumers can refer to the recall announcement for the complete list of affected lot numbers.

Consumers 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.

The FDA also encourages patients and medical professionals to report any adverse reactions or quality problems they experienced while using the Cardinal Health Monoject syringes to the MedWatch Adverse Event Reporting Program.