The FDA has identified another recall for the Alaris infusion pump from BD (NYSE:BDX) as Class I, the most serious kind of recall.
BD’s latest recall, initiated on March 3, 2021, involves its BD Alaris infusion pump module system, which includes an infusion pump and vital signs monitoring system with a PC unit, the Guardrails Suite MX and up to four removable infusion or monitoring modules (channels), according to an FDA notice.
CareFusion 303 Inc. is recalling the Alaris pump module because there is a risk of the keypad lifting up due to fluid entry, an issue that could result in keys that become unresponsive or stuck. That could lead to an infusion delay or interruption, or it could prevent clinicians from changing fluid or medication infusions on the affected devices. Such delays or interruptions could cause serious injury or death.
To date, there have been 79 complaints regarding the device issue, but no reports of injuries or death. The recall is separate from an August recall of the Alaris pump module 8100 keypad for stuck keys, though BD spokesperson Troy Kirkpatrick tells Drug Delivery Business News and MassDevice that devices remediated in the August recall do not need remediation a second time.
Affected products in the latest recall were manufactured between Jan. 15, 2019, and Dec. 5, 2019, and distributed between Jan. 23, 2019, and Dec. 5, 2019. So far, 145,492 devices have been recalled in the U.S. Kirkpatrick said the cause involved a supplier manufacturing issue.
Franklin Lakes, N.J.–based BD has had shipments of Alaris pumps on hold since 2020 after the FDA called for a comprehensive 510(k) submission to cover a host of software fixes needed after a different Class I-level recall. Pumps are only going to health providers with an immediate medical need.
In November, the company disclosed that it set aside $244 million to cover future product remediation costs, including its effort to fix the problematic Alaris pumps.
