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

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...