Initiating a Voluntary Medical Device Recall—Mike on Medtech

Initiating a Voluntary Medical Device Recall—Mike on Medtech

Mike Drues and Sean Fenske discuss recalls with a specific focus on voluntary recalls, why they occur, and how to be ready for one.

By Sean Fenske, Editor-in-Chief10.11.22
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we examine medical device recalls. More specifically, the focus of the discussion is on voluntary recalls, why they occur, and why companies need to be ready to conduct a recall. The FDA’s involvement with a recall is also presented as well as what “recall ready” means. Specifically, the following questions are addressed:

  • Can you start by explaining what a voluntary recall is and why or when it’s used?
  • Is there any differences in the process for a voluntary recall across any of FDA’s categories, such as pharma, medical device, food, etc.?
  • Is there a non-voluntary recall (or one that is ordered)? If so, how is that different?
  • The FDA states a company within a product distribution chain needs to be “recall ready.” What does this mean?
  • What are the steps in a voluntary recall?
  • Is the FDA involved in a voluntary recall beyond being notified? If so, how?
  • How do you ensure everyone who needs to be contacted about a recall is reached?
  • What are the most important takeaways companies need to keep in mind about voluntary recalls?

Listen to this episode and see if you better understand voluntary recalls. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at sfenske@rodmanmedia.com and we’ll see if we want to address your ideas/inquiries/suggestions in a future episode.

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