Dive Brief:
- Cardinal Health is removing a list of its own brand of Monoject sterile syringes from the U.S. market, the company said Friday, expanding on previous actions to address compatibility problems with infusion pumps.
- The product removal supersedes two communications Cardinal issued last year after learning that some Monoject syringes are incompatible with certain infusion pumps. Cardinal apologized for “any frustration these changes and resulting issues have caused” and said the latest notice is intended to “reduce confusion and create a simplified course of action” for customers.
- The company has not received any reports of patient death, but noted the potential risk of serious injury or death. The failure of an infusion pump to recognize a syringe could delay treatment. Alternatively, if a syringe is recognized, the pump may provide too much or too little medicine.
Dive Insight:
In September, Cardinal told customers about “recognition and compatibility issues” between Monoject sterile syringes and syringe pumps. The Food and Drug Administration categorized the notice as a Class I recall in November, noting that the recall did not require product removal. Days later, the FDA published a second notice to raise concerns that Cardinal had failed to sufficiently mitigate the risk of incompatibility.
On Friday, the company announced a recall for the removal of all sizes of two Cardinal Health-brand Monoject syringes, and the FDA released its own notice publicizing the action. Cardinal said it issued the product removal “in close coordination” with the FDA.
Under the new advice, healthcare providers should immediately stop using seven sizes of Cardinal Health brand Monoject Luer-Lock Tip sterile syringes and six sizes of Cardinal Health brand Monoject Enteral sterile syringes with the Enfit connection. Cardinal has provided instructions for returning the affected products.
As of Jan. 25, Cardinal had received 32 complaints of syringe infusion pumps and one report of patient controlled-analgesia pumps not recognizing its own-brand Monoject sterile LuerLock syringes, according to a notice the company provided to MedTech Dive. The company had also received nine complaints about enteral syringe pumps not recognizing Enteral sterile syringes with the Enfit connection.
None of the notices apply to Covidien brand Monoject syringes, which are made by a different contract manufacturer and have different dimensions than the recalled products.
