Crimson Audit & Review

Content Audit, Review & Consulting for Medical Device Makers

Labeling Errors are Leading Cause of Device Recall

Posted by crimsonlanguage on 2010/03/17

“Cast your bread upon the waters”

– Ecclesiastes 11:1-2

Recently, I attempted to verify an anecdote that gets thrown around in the world of medical device labeling: Labeling errors are the leading cause of device recalls. Sounds plausible, but is it true?

To answer this question, I turned to the Institute of Packaging Professionals ( – their Medical Device Packaging TC looked like a promising source of information.

Three weeks after submitting my inquiry (I’d nearly forgotten all about it)  a call came in from Harold Reisman, Packaging Project Manager for Davol (C.R. Bard) and well-informed spokesman for the IoPP Medical Device TC.

Did I still need an answer?…Why, yes! Turns out, Harold’s Master’s thesis (Packaging Postponement: Solving the Medical Device Ever – Changing Requirements) reviewed FDA data on precisely this issue. In 2006 and 2007, labeling-related recalls made up 55% of all recalls – so, the majority. Since 2007, labeling-related recalls, as a majority of all recalls, has remained constant.

This simple statistic highlights yet another risk management consideration for labeling. Combined with the fundamental issue of patient safety, the risk of recall makes a strong argument for robust processes and highly qualified resources.

One Response to “Labeling Errors are Leading Cause of Device Recall”

  1. […] Since 2009, I’ve written an occasional blog for Crimson Life Sciences – the founding division of EnCompass solutions. In over 4 years, the most popular post (by far) has been this:  Labeling Errors are Leading Cause of Device Recall. […]

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