BD’s Alaris Infusion Pump Gets 510(k) Clearance After 2020 Class I Recall

BD has received 510(k) clearance for both remediation and return to full commercial operations of its updated Alaris infusion pump system, which was subject to an FDA class I recall in 2020, the most serious type of recall as use of the device may lead to serious injury or death.

The system is used in hospitals and other healthcare facilities to deliver controlled amounts of medications, fluids, blood and blood products into a patient’s body.

The company initiated a recall in August 2020 for its BD Alaris PC Unit 8015 along with five keypad replacement kits, because one or more keys may become unresponsive or stuck, an issue which resulted in 1,186 complaints and one injury.

The company says the updated system addresses all open recalls and covers updated hardware features for the point of care unit, large volume pumps, syringe pumps, patient-controlled analgesia pumps and respiratory monitoring and auto-identification modules as well as enhanced cybersecurity for interoperability with electronic medical record systems. The point of care unit controls all the models, which is different, the company says, from all other pumps on the market.

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