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  • A medical-device maker issued a recall of some sterilization containers over potential breaches.
  • The WSJ reported Becton Dickinson found evidence the breaches could lead to patient infections. 
  • It applies to 17 versions of the reusable metal containers, sold under the Genesis Sterrad brand.

Medical-device maker Beckton Dickinson has issued a voluntary recall of some sterilization containers, fearing that breaches in the containers could lead to an increased risk of patient infections.

The Wall Street Journal reported the story citing a company letter sent to customers this week.

Becton Dickinson found evidence some containers, sold under the Genesis Sterrad brand in the United States and Canada, used to sterilize surgical instruments may have had breaches. 

The company said the 17 versions of the reusable metal containers haven’t consistently met testing requirements for a quality test known as an aerosol challenge in 2011, in which the containers are exposed to aerosolized microbes to see whether they penetrate the container. 

The failing tests mean the containers won’t keep surgical tools sterile, which “might lead to transmission of infectious pathogens to the surgical patient,” potentially causing fevers, chills, abscess formation, or sepsis, according to the letter obtained by the Journal. 

A Becton Dickinson spokesperson told the outlet that about 8,075 Genesis containers are being recalled, including 6,777 in the US, and confirmed the containers were discontinued earlier this year.

Becton Dickinson did not immediately respond to a request for comment from Insider made outside regular business hours Saturday.

The medical-device maker also said there have been no reports of adverse events associated with this issue and shared the test results with the Food and Drug Administration.

The FDA didn’t immediately respond to Insider’s request for comment, which was made outside regular business hours Saturday.

The company, which acquired the Genesis Sterrad line of reusable containers in 2015 as part of its $12 billion takeover of CareFusion Corp, told Reuters: “It is very unlikely that a number of products are still in use, as most hospitals have moved away from these discontinued Sterrad systems over the past several years.”



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