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BD Announces FDA Classifications for August 4th Recalls of BD Alaris™ System Hardware for Keypads...

Thursday, September 24, 2020   (0 Comments)
Posted by: Andrea Guidi
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BD Announces FDA Classifications for August 4th Recalls of BD Alaris™ System Hardware for Keypads, Incorrect Module Types and/or Sizes, and Channel Error

Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Medical Devices
Reason for Announcement:
Potential for four hardware situations that may result in the infusion pump not operating as expected
Company Name:
Becton, Dickinson and Company
Brand Name:
Alaris
Product Description:
BD Alaris System Hardware

Company Announcement

Three Recalls Designated as Class I by FDA; One Designated as Class II

BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today provided an update on  previously announced voluntary recalls of the BD Alaris™ System.

Three of the recalls, which BD announced on Aug. 4, 2020External Link Disclaimer,External Link Disclaimer have been designated as Class I recalls by the U.S. Food and Drug Administration (FDA), which means that FDA has determined that there is a reasonable probability that the use of the product will cause serious adverse health consequences or death. One of the situations was designated as a Class II recall, which means use of the product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

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This website was updated in 2015 with a generous grant from Shire, Inc. This website is an educational resource. It is not intended to provide medical advice or recommend a course of treatment. You should discuss all issues, ideas, suggestions, etc. with your clinician prior to use. Clinicians in a relevant field have reviewed the medical information; however, the Oley Foundation does not guarantee the accuracy of the information presented, and is not liable if information is incorrect or incomplete. If you have questions please contact Oley staff.
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