Becton, Dickinson ( NYSE: BDX ) has announced a voluntary recall of certain special containers that hospitals use to sterilize surgical tools after tests indicated breaches in some products that could lead to infections, The Wall Street Journal reported Friday.
Sold under the Genesis Sterrad brand name, the reusable metal containers have failed to constantly meet a quality standard called the aerosol challenge, which might suggest potential contamination under conditions outside their regular use.
This “might lead to transmission of infectious pathogens to the surgical patient,” the company has informed its customers in a letter, adding that there were no adverse events linked to the issue.
The recall doesn’t apply to all Genesis containers, and the company advised customers to dispose of the affected products for which it plans to issue credit.
8,075 Genesis containers, including 6,777 units in the U.S. distributed between April 2011 and August 2022, are being recalled, a Becton ( BDX ) spokesperson said, adding that the recall represents fewer than 1% of sterilization container sales over the past five-year period.
The decision comes after Hooman Noorchashm, a former BDX medical director, recently raised concerns to the FDA about the Genesis containers, citing failed aerosol challenge tests. Dr. Noorchashm alleges that BDX wrongfully terminated him in August after he voiced dissent regarding how the company handled the issue.
BDX added the Genesis brand with its 2015 acquisition of CareFusion Corporation for over $12B.
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Becton, Dickinson issues voluntary recall of sterilization containers – WSJ