Becton recalls some sterilization containers due to quality breach (updated)

Becton Dickinson and Co

07/10/2022 22:12

(Updates sourcing, adds company statement)
       Oct 7 (Reuters) - Becton Dickinson & Co  BDX.N  is
recalling some models of its sterilization containers sold under
the Genesis Sterrad brand in the United States and Canada, the
company said on Friday, citing "discrepant test results" during
an internal quality assessment.
    The company said it had found the recalled product models
had conflicting results for a quality test known as aerosol
challenge in 2011. 
    Becton said the aerosol challenge, in which the containers
are exposed to aerosol particles to check whether they enter,
was not a required test by the U.S. Food and Drug Administration
when the products were originally cleared. 
     The Genesis Sterrad line of reusable containers, which
Becton acquired in 2015 as part of its $12 billion takeover of
CareFusion Corp, are used by hospitals for storing surgical
instruments before and after sterilization. 
    Becton said there have been no reports of adverse events
associated with this issue and it has shared the discrepant test
results with the U.S. health regulator before initiating the
recall. 
    The products subject to recall represent less than 1% of
total sterilization container units sold over the last five
years and would have no material financial impact on the
company, Becton told Reuters. 
    The total recalled units, which span an 11-year period, are
8,075, and 6,777 of those were in the U.S. 
    "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," the company said. 
    The recall was first reported by Wall Street Journal, citing
a company letter to customers sent this week. 
 (Reporting by Bhanvi Satija in Bengaluru; Editing by Krishna
Chandra Eluri)
 ((Bhanvi.Satija@thomsonreuters.com; Outside U.S. +91
9873062788;))