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Which of the following events will trigger a recall after a processed medical device is released?

  1. If a positive BI PCD result was obtained

  2. No growth on BI PCD

  3. Negative result on chemical indicator

  4. No change in color on external indicator

The correct answer is: If a positive BI PCD result was obtained

If a positive biological indicator (BI) process challenge device (PCD) result is obtained after a processed medical device has been released, it would trigger a recall. This is because a positive result indicates that the sterilization process was not effective, and there is a risk that the medical devices processed in that cycle are not sterile. Therefore, any positive BI PCD result warrants immediate action to prevent the use of non-sterile medical devices on patients. The other options do not necessarily indicate a sterilization failure that would require a recall: - No growth on the BI PCD indicates that the sterilization process was successful. - A negative result on a chemical indicator also indicates that the sterilization process was successful. - No change in color on an external indicator does not provide information about the effectiveness of the sterilization process.