The U.S. Food & Drug Administration (FDA) has announced a nationwide recall for 1 lot of Comfort Shield Barrier Cream Cloths over potential contamination with B. cepacia, a bacteria that can cause life-threatening infections in hospitalized patients and others with compromised immune systems.
Free Confidential Lawsuit Evaluation: If you got an infection after using barrier cream cloths, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against the manufacturer and our lawyers can help.
Update: Liquid Stool Softeners Recalled for B. Cepacia Contamination
August 9, 2017 – Rugby Laboratories is recalling its Diocto liquid and Diocto syrup laxatives over potential contamination with B. cepacia, according to an FDA Recall Notice issued Tuesday. The agency notified Rugby of the problem after receiving several reports of infection in patients who had used the laxatives.
Comfort Shield Cloths Recalled Due to Microbial Contamination
August 1, 2016 – Comfort Shield Barrier Cream Cloths are a non-sterile, topical skin protectant used to treat skin irritation caused by urine and/or stool exposure. Products affected by this recall include:
- Comfort Shield Barrier Cream Cloths: Product Code 7503; NDC Number 53462-915-50; Lot Number 53957; Expiration Date 3/6/2018.
These products were distributed to distributors and healthcare facilities in the U.S. between March 31, 2016 and June 8, 2016. To date, no adverse events have been linked to this recall.
What is B. Cepacia?
Burkholderia cepacia, or B. cepacia, is the name for a group of antibiotic resistant bacteria commonly found in soil and water. The bacteria are rarely harmful to healthy adults; however, people who weakened immune systems or chronic lung diseases like cystic fibrosis may be more susceptible to infections with B. cepacia. It is also a known cause of infection in hospitalized patients.
Signs and symptoms of B. cepacia infection include:
- Shortness of breath
Customers who received barrier cream cloths affected by this recall should stop using them immediately and contact Sage Products for a refund. Patients with any of the above symptoms should call their doctor right away and report adverse reactions to the FDA’s MedWatch Adverse Event Reporting program.
More Skin Products Recalled Over Potential Microbial Contamination
September 6, 2016 – Sage Products is again expanding its global recall of topical skin products over potential contamination with B. cepacia. Products affected by the expanded recall include Comfort Shield Barrier Cream Cloths, Incontinence Clean-Up Cloths, M-care Meatal Cleansing Cloths for the Foley Catheterized Patient, Comfort Bath Cleansing Washcloths, and 2% Chlorhexidine Gluconate Cloths. All of these products are single-use, disposable cloths that were distributed worldwide from August 2014 to August 2016.
Barrier Cream Cloth Recall Expanded
August 12, 2016 – Sage Products is expanding its nationwide recall to include an additional lot of Comfort Shield Barrier Cream Cloths over potential contamination with B. cepacia bacteria. This action affects Product Code 7905; NDC Number 53462-915-80; Lot Number 55781; Expiration Date 6/9/2018.
Do I Have a Barrier Cream Cloth Lawsuit?
The Class Action Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in barrier cream cloth lawsuits. We are handling individual litigation nationwide and currently accepting new injury and death cases in all 50 states.
Free Confidential Case Evaluation: Again, if you were injured, you should contact our law firm immediately. You may be entitled to a settlement by filing a suit we can help.