Sunstar—SUNSTAR Butler Clear Dip: May Be Contaminated with Burkholderia contaminans

April 21, 2021 | Strategic Insights for Health System

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ECRI's complete weekly summary of medical device hazard and recall information is available in ECRI's Health Device Alerts. For more information contact us at clientservices@ecri.org. ​

Problem:FDA's Center for Devices and Radiological Health (CDRH) states that the above products may be contaminated with Burkholderia contaminans. FDA's CDRH further states that the manufacturer initiated a recall by letter on March 23, 2021. The manufacturer has not confirmed the...

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