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.
Cardinal Health recently changed the dimensions for Monoject syringes during a rebranding effort from their previous Covidien title. These updated syringes haven’t been validated for use with BD Alaris syringe and PCA modules. When used with the updated Monoject under previous syringe settings, the pump may either refuse to operate or incorrectly estimate the volume of liquid in the syringe.
BD said this issue led to over- and under-infusions, plus delays in therapy. The company received 13 reported injuries and no reports of death to date.
Affected products include the BD Alaris syringe module, the Alaris PCU and the Alaris PCA module. The recall affects model numbers 8110, 8015 and 8120. BD distributed affected devices between June 19, 2004, and Sept. 22, 2023.
To date, the recall has affected 220,120 syringe pump and PCA modules and 867,362 PCU modules. BD initiated the recall on Sept. 15, 2023.
