In the latest Alaris recall, the company cites compatibility issues with Cardinal Health Monoject syringes. The issue mainly relates to changes made to the products by Cardinal Health. It affects more than 1 million total devices.
BD’s Alaris system has been much maligned over the past few years, going back to a Class I recall in early 2020. The recall, which centered around multiple system errors, software errors, and use-related errors, led to a long-term shipping hold on the pumps.
However, the company resumed Alaris distribution after receiving updated FDA clearance in July, seemingly putting those issues in the past.
An FDA notice distributed last week says the company recalled more Alaris pumps this time due to the syringe compatibility issues. Alaris pumps are validated for use with Monoject syringes and list it as an option when users select their syringe type.
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