Just a week after issuing a notice giving its most serious rating to Cardinal Health’s recall of certain syringes, the FDA has put out a letter to healthcare providers warning that the recall may not go far enough.
Cardinal began the recall in September, when it alerted customers to the possibility that some of its single-use, luer-lock tip Monoject syringes were incompatible with syringe pumps and could therefore lead to underdoses or overdoses of pump-delivered medications and fluids as well as delays in proper therapy or missed occlusion alarms.
The devicemaker traced the issue back to differences in the manufacturing of the syringes that gave them slightly different dimensions than their predecessors, which had been sold with Covidien branding—since the Monoject line of syringes were previously distributed by the Medtronic subsidiary before they were acquired by Cardinal several years ago.
The company warned healthcare providers not to use the affected Cardinal-branded syringes, more than 32.4 million of which were distributed in the U.S. between June and August of this year.
In last week’s notice, which gave the recall a Class I rating, the FDA noted that Cardinal had received 15 reports of delays in syringe pump therapy and 13 reports of inaccurate medication dispensing, some of which reportedly led to unspecified patient injuries, related to the faulty syringes.
Monday, the FDA issued a follow-up warning, suggesting that the issues with Cardinal’s syringes may reach even further than previously described.
For one thing, the agency recommended that the affected Monoject syringes not be used with patient-controlled analgesia (PCA) pumps, in addition to syringe pumps. While syringe pumps are similar to infusion pumps and automatically dole out needed doses of medications, blood and other fluids—albeit in smaller quantities than infusion pumps—PCA pumps allow hospitalized patients to control the delivery of pain medication themselves using a hand-held button.
In the Nov. 20 notice, the regulator acknowledged Cardinal’s previous warnings about the syringes’ incompatibility with syringe pumps but added, “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.”
The FDA went on to suggest that the incompatibility at the heart of the recall “could apply to additional sizes of Cardinal Health Monoject syringes” beyond those already noted by Cardinal.
To date, the recall includes 1-, 6-, 12-, 20-, 35- and 60-mL sizes of Cardinal-branded, luer-lock tip Monoject syringes. The company also sells 10- and 140-mL versions of its standard syringes, and all are available in either sterile or non-sterile iterations, with several tip designs to choose from.
The FDA said it’s currently working with Cardinal to determine the full scope of the recall. In the meantime, it advised healthcare providers to stop using Cardinal-branded Monoject syringes with both PCA and syringe pumps but noted that Covidien-branded syringes are still safe to use.