The recall list includes 17 versions of the reusable metal containers, sold under the Genesis Sterrad brand, which store surgical tools like scissors and forceps during and after sterilisation
BD has recalled sterilisation containers, sold under the Genesis Sterrad brand in the US and Canada, citing a potential quality breach. (Credit: Ri Butov from Pixabay)
Becton, Dickinson & Co. (BD) has recalled sterilisation containers, sold under the Genesis Sterrad brand in the US and Canada, citing a potential quality breach that can cause infections in patients.
The American medical technology company said that the move was based on the discrepant test results emerging from an internal quality assessment.
The recall list includes 17 versions of the Genesis Sterrad reusable metal containers, which store surgical tools like forceps and scissors during and after sterilisation.
According to Becton, Dickinson, the recalled product models produced contradictory findings in a quality test called aerosol challenge. In the test, the containers were subjected to aerosolised germs to examine if they can enter the container.
However, the containers didn’t meet the testing requirements.
Becton, Dickinson said that the results indicate that the containers won’t maintain the sterility of surgical instruments in settings other than those of routine usage.
In a letter to consumers, the firm warned that this could lead to the transmission of infectious germs to the surgical patient, which might result in fevers, chills, the development of abscesses, sepsis, and deterioration if ignored.
The Genesis Sterrad brand of reusable containers was added to Becton, Dickinson as part of its $12bn acquisition of CareFusion in 2015.
Before starting the recall, Becton, Dickinson claimed it had shared the test findings with the American health authority and reported no complaints of adverse events linked to the problem.
The total recalled units are 8,075, out of which 6,777 were in the US, Becton, Dickinson said. The recalled products are said to be less than 1% of the total sales of sterilisation containers over the past five years.
Becton, Dickinson said that the recalled Genesis containers were distributed from April 2011 to August 2022 and it does not include all the containers of the brand.
Becton, Dickinson said: “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.”