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HomeRegulatory & QualityWhen Is a Recall Not a Recall?

When Is a Recall Not a Recall?

The Star Tribune of Minneapolis-St. Paul, MN has an article about an interesting proposal from the Heart Rhythm Society, contained in its report discussed in this space earlier: Eliminating the word "recall" when advising the public about a medical device malfunction. The word "recall" tends to cause alarm because it implies that the product is unsafe and the problem is so serious that the product must be fixed or replaced immediately.

May 15, 2006

But as applied to devices, it just means that the device could fail, and may not imply that it is life-threatening.Â In non-life-threatening cases, the terms "advisory notice" or "safety alert" would be more appropriate, the report states. AdvaMed is on record as agreeing, and FDA says it will consider the proposal. It seems like a good idea provided that life-threatening problems are still reported with urgent language. Also of note is that the Star Tribune article did an excellent job of differentiating devices from drugs, which eludes much mainstream media coverage.

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