In January, Triad Group announced a voluntary recall of alcohol prep pads, wipes, swabs and swabsticks. The recall was initiated due to potential concerns about contamination of the products with Bacillus cereus, a type of bacteria found in soil and most commonly associated with foodborne illnesses.
Using the contaminated Triad Group products may lead to life-threatening infections, especially in-at risk populations, including surgical and immune suppressed patients. Symptoms may appear within 24 hours of using the contaminated product, and may include:
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- Difficulty breathing
- Signs of infection at the site, which may include redness and swelling
Regular users of injectable medications, including drugs used to treat diabetes, rheumatoid arthritis or Multiple Sclerosis (MS), are also at a high risk of infection. This is due to regular use of alcohol wipes to disinfect an injection site, potentially exposing it to the bacterial contamination on affected Triad products, and then piercing the skin during the injection of the medication.
Sold nationwide at drug stores, including CVS and Walgreens, the recall involves products marked as STERILE as well as non-sterile products. The manufactururer may be listed on the packaging as Triad Group. If the products are manufactured for a third party, the manufacturer may be listed as a private label brand, including: Cardinal Health, PSS Select, VersaPro, Boca Ultilet, Moore Medical, Walgreens, CVS, and Conzellinand.
In addition to prep pads for single use, the alcohol pads and swabs are also prepacked in many drug and surgical instrument packets. Manufacturers of products prepackaged with the recalled alcohol wipes state that the Triad recall does not affect or involve other components of the kit and that consumers may continue use of the product; however, these manufacturers also reiterate that consumers should use a different brand of packaged alcohol wipes. Some of the recalled products may be packaged with:
- Pfizer Inc and Progenics Pharmaceuticals, Inc. RELISTOR kits
- GlaxoSmithKline (GSK) ARIXTRA® Starter Kits
- Genentech, Inc. medicines Boniva Injection, Fuzeon, Nutropin A.Q. Pen, Pegasys, and TNKase
The FDA regularly updates an extensive list of drug and surgical instrument packets that contain the recalled alcohol wipes. The list may be viewed by clicking here.
FDA Knowledge of Triad Group Manufacturing Plant
A recent article from MSNBC alleges that the FDA knew of contamination problems at the Triad Group manufacturing plant as early as 2009; however, the website claims that “there’s no record that the FDA sent warning letters typically used to force firms to comply.” In addition, msnbc.com states that “Inspectors reported that the company could not validate the processes used to ensure quality or sterility not only of alcohol prep pads and wipes, but also other products used for intimate care.” These products include hemorrhoid creams; infant and adult glycerin suppositories; and sterile lubricating jelly used in homes, plus clinics and hospitals for medical exams.
If you have any of the Triad Group alcohol prep pads, wipes, swabsticks or swabs, do not use the product. If you believe that you have been harmed by Triad Group products contaminated by Bacillus cereus bacteria, save the product in a sealed container. Do not return the product to the location it was purchased from until contacting Burnetti, P.A. to determine your legal rights.
Feb. 16, 2011 – FoxNews.com Reports “Parents Blame Tainted Alcohol Swabs for Toddler’s Death”
Feb. 22, 2011 – MSNBC.com Reports “FDA knew of problems at plant that made tainted alcohol wipes”
March 7, 2011 – MSNBC.com announces that a Colorado hospital discovered the contaminated Triad alcohol wipes.
March 14, 2011 – MSNBC.com reports that Triad Group is closing their health care line – “at least for now.”
March 17, 2011 – Eli Lilly and Company announces some Forteo® starter kits distributed between March 2008 and June 2009 may contain contaminated Triad Group alcohol prep pads. The recall does not affect or involve the Fortero Delivery Device, but consumers should not use the Triad Group alcohol wipes included in the kit.
March 18, 2011 – Triad Group Announces Another Recall – Povidine Iodine Prep Pads May be Contaminated with Bacteria
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