(Reuters) – Medical device-maker Becton Dickinson & Co has issued a voluntary recall of 17 versions of its sterilization containers, according to a Wall Street Journal report on Friday citing a company letter to customers sent this week.
The reusable containers, which are sold under the brand name Genesis Sterrad, are used by hospitals for storing surgical instruments before and after sterilization.
The recall applies to versions of the containers which were distributed between April 2011 and August 2022, according to the report.
The company, according to the WSJ report, said the containers have not “consistently met testing requirements” for a type of quality test known as aerosol challenge, in which they are exposed to aerosol particles to check whether they enter the container.
The report, citing a company spokesman, added that about 8,075 Genesis containers were being recalled, including 6,777 in the U.S. Becton has said there have been no reports of adverse events associated with this issue, the report added.
Becton Dickinson and the U.S. Food and Drug Administration did not immediately respond to Reuters’ requests for comments.
(Reporting by Bhanvi Satija in Bengaluru; Editing by Krishna Chandra Eluri)