Comfort Shield Barrier Cream Cloth Recall
In a voluntary recall, Sage Products called back one lot of its Comfort Shield Barrier Cream Cloths to the points of distribution from health care facilities, pharmacies, and at-home patients nationwide. The product was recalled because it was contaminated by Burkholderia cepacia, or B. cepacia. This is a serious infection that cannot be treated easily and several instances of infections were reported.
Sage has been providing medical supplies to the healthcare industry since 1971 and has a history of providing quality products to the market through its distributors.
Infection of B. cepacia can be life-threatening in some cases; particularly, where patients have underlying or pre-existing conditions that can be made worse by the presence of infection. In a recent study, mortality rates in people with cystic fibrosis were 35% more likely to perish than people who didn’t have a pre-existing condition. The bacterial infection is not easily treated with antibiotics, and in some cases, it is antibiotic resistant altogether.
The recall of the Comfort Shield Barrier Cream Cloths, which are used to help protect and treat moisture associated with urine and stool exposure, including products distributed between March 31, 2016, and June 8, 2016. The lot number of the recall was 53957 initially but then was expanded, voluntarily, to include another lot number of 55781.
The topical application of the clothes was causing people to become infected with the B. cepacia infection in the hospital as well as in home settings.
One study recently conducted provided some hope for the treatment of B. cepacia by breaking down the proteins found on the bacteria; they could make the infection more susceptible to antibiotics overall and improve the chances of recovery and survival, particularly in patients who suffered from cystic fibrosis.
This is actually the second time Sage has had to recall a product because of contamination on a global scale. The recall also includes incontinence clean-up cloths, M-care Meatal Cleansing Cloths for patients with Foley catheters, Comfort Bath Cleansing Washcloths, and 2% Chlorhexidine Gluconate Cloths. All of these products offer one-time use, disposable cloths that were distributed from August 2014 to August 2016 worldwide including United States, Canada, El Salvador, Singapore, Saudi Arabia, Portugal, the Netherlands, Malaysia, Mexico, Australia, Ireland, Honduras, United Kingdom, Denmark, Germany, Bahrain, and the United Arab Emirates.
Similar infections were related to another recent recall from PharamTech involved a stool softening product called Diocto. This was distributed by a number of retail companies and distributors and was recalled twice over the last year due to contamination of B. cepacia.
Typical signs and symptoms of the antibiotic-resistant infection include high fevers, persistent coughing, congestion, shortness of breath and the presence of wheezing while breathing. If you experience any of these symptoms, contact your health provider immediately and report your symptoms to the Food and Drug Administration as soon as possible. There is a form that you can fill out on their website to report any outbreaks or instances of infection related to this, or other product recalls in the health industry.
Our Firm is Here to Help Those Who’ve Been Injured
Burkholderia cepacia infections are serious and can be life threatening. It’s unacceptable for a pharmaceutical company to have a recall of their products due to contamination of a dangerous bacteria. The Hastings Law Firm is interviewing potential cases involving B. Cepacia injuries across all 50 states. If you or a loved one has contracted a B. Cepacia bacterial infection from exposure to tainted Sage brand products then contact our attorneys immediately.
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