Cardinal Health Grapples With Class I Recall of 32 Million Syringes Amidst Safety Concerns

In a recent development, Cardinal Health is contending with a substantial setback as the U.S. Food and Drug Administration (FDA) issues a Class I recall for over 32 million disposable syringes. This rigorous classification, reserved for products believed to pose a severe risk of causing serious injuries or death, has cast a spotlight on Cardinal Health’s Monoject syringes, which were introduced into the market in June 2023.

The crux of the matter lies in the meticulous design of these newer Monoject syringes, distinct from their Covidien counterparts, and their unintended incompatibility with syringe pumps. The FDA has elucidated that the altered dimensions of the Cardinal Health Monoject syringes can lead to a myriad of pump-related issues, including the potential for overdose, underdose, therapy delays, and occlusion alarm delays. This revelation prompted the FDA to elevate the recall to the most severe classification, Class I, signifying the gravity of the associated risks.

A staggering 32.43 million disposable syringes, distributed between June and August 2023, are now subject to this recall. The FDA has thoughtfully compiled a comprehensive list of affected product names and codes, accessible through their official advisory. It is imperative for healthcare providers and facilities to meticulously cross-reference their inventory with this list to ensure the prompt identification and isolation of the recalled syringes.

In the wake of this recall, Cardinal Health has reported 15 instances where therapy was significantly delayed due to the incompatibility issue. Additionally, there have been 13 reports highlighting inaccuracies in volume and rate dispensing, raising concerns about patient safety. Importantly, the FDA is emphatic in categorizing this recall not as a routine correction but as a stern warning against the use of Cardinal Health Monoject syringes in conjunction with syringe infusion pumps.

Interestingly, the pre-existing Covidien-branded Monoject syringes, which were assimilated into Cardinal Health’s product line following the acquisition of certain medical supplies from Medtronic, remain unaffected by this compatibility issue. Healthcare practitioners can continue to use the Covidien-branded versions with syringe infusion pumps, offering a crucial alternative in maintaining patient care standards.

This recent recall echoes a previous incident in 2021 when Cardinal Health initiated a recall involving approximately 267 million Monoject syringes prefilled with saline solution. The recall stemmed from flawed plunger mechanisms that could potentially lead to air embolism if injected into a patient’s bloodstream. Despite 37 complaints related to the plunger issue, Cardinal Health reported no injuries or fatalities, highlighting the proactive stance taken by the company in addressing safety concerns.