In a letter alerting customers of the recall, BD said some products failed a test that assesses whether aerosol microbes could penetrate the containers. The devicemaker said it can’t guarantee the containers will keep surgical tools sterile under conditions outside of normal use, which could pose an infection risk to surgical patients.
The recall applies to 8,075 containers sold under the Genesis Sterrad brand distributed globally between April 2011 and August 2022. About 6,700 containers were sold in the U.S., a BD spokesperson told the Journal.
The company has not received any reports of adverse events associated with the sterility issue. Hospitals should dispose of any containers involved in the recall and will receive a credit from BD.
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