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FDA’s First ‘Early Alert’ Under New Communications Pilot Targets Fresenius Infusion Pumps

 
• By Brian Bossetta

The US FDA has issued its first communication as part of a new pilot program the agency initiated to increase transparency in recalls of high-risk medical devices. The early alerts are meant to minimize the time between the FDA finding out about a potential issue and informing stakeholders.

The Food and Drug Administration issued an alert on 11 December regarding a potential hazard with infusion pumps from Fresenius Kabi USA.

The communication, which specifically relates to the company’s Ivenix large-volume pump — the LVP-0004 — marks the first warning issued under the FDA’s

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