Stryker‘s (NYSE:SYK) Sage Products subsidiary is expanding its voluntary worldwide recall to include lots of impregnated cloth topical skin products over contamination issues with the bacteria Burkholderia cepacia, according to an FDA notice.
The recall includes Sage Products’ Comfort Shield barrier cloths, incontinence clean-up cloths, M-care meatal cleansing cloths, Comfort Bath cleansing washcloths and .2% chlorhexidine gluconate cloths.
Use of the products contaminated with B. cepacia could cause serious infections in patients with compromised immune systems or in hospitalized patients which could be life threatening, according to an FDA notice.
The company recalled products distributed between August 2014 and August 2016 across multiple supply lines including healthcare facilities and retailers in the U.S., Canada, El Salvador, Singapore, Saudi Arabia, Portugal, the Netherlands, Malaysia, Mexico, Australia, Ireland, Honduras, United Kingdom, Denmark, Germany, Bahrain, and United Arab Emirates.
The B. cepacia bacteria has been at the heart of other FDA recalls, including a number of benzalkonium chloride swabs and antiseptic wipes in 2012, a lot of Zicam extreme congestion relief and babywipes from multiple brands in 2014 and Diocto Liquid docusate sodium solution earlier this year.
Sage Products said it is notifying customers with the products of the recall and advised customers to return the affected products to the company for credit.
In April, Stryker said it closed its $2.7 billion buyout of Sage Products, which makes a line of disposable devices designed to reduce so-called “never events” in intensive care and surgical settings, which was announced Feb. 1.