Becton Dickinson (NYSE:BDX) issued an urgent field safety notice to warn customers in Europe of an issue with specific lots of its Alaris extension sets.
Through customer feedback, the company found the potential for the male luer of the Alaris extension set to become disconnected from the female luer of the connecting device, both upon initial connection and/or during infusion. Disconnection of the luers could result in leakage of medication and potential interruption of therapy, according to the safety notice.
The Alaris extension sets are manufactured by Shanghai Kindly Enterprise Development Group and distributed by Becton Dickinson subsidiary CareFusion.
In July 2019, BD updated recalls on the Alaris pumps and infusion sets following an initial recall on April 15, when BD notified clinicians that the manufacturing process of the pumps resulted in weakened plastic. Over time, the weakened plastic could lead to free flow, over-infusion, under-infusion or interruption of the infusion. The July recall urged hospitals to destroy all affected products found in their inventories.
Becton Dickinson also acknowledged that ongoing issues with the Alaris pump resulted in the company lowering its 2020 financial guidance.
The latest issue with the device has prompted the medtech giant to urge users to inspect inventory and quarantine any impacted devices. BD also said users should destroy unused units of specific products as well.
