The FDA has ordered Custom Ultrasonics to recall all of its automated endoscope reprocessors from healthcare facilities.
Here are six things to know:
1. The FDA ordered the recall due to "the firm's continued violations of federal law and a consent decree entered with the company in 2007."
2. The violations could result in infection transmission, and under the terms of the consent decree, ordered the recall.
3. Around 2,800 automated endoscope reprocessors manufactured by Custom Ultrasonics are currently in hospitals and outpatient clinics throughout the country.
4. The recall order applies to all Custom Ultrasonics AERs, including the System 83 Plus, System 83 Plus 2 and System 83 Plus 9.
5. The FDA's most recent inspection of Custom Ultrasonics' facility occurred in April 2015, during which a number of violations were documented.
6. The agency also issued a safety communication recommending that healthcare facilities transition away from using Custom Ultrasonics AERs as soon as possible.
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