FOR IMMEDIATE RELEASE — Oct. 25, 2014 — MCELHATTAN, PA — Nutek Disposables, Inc. of McElhattan, PA has initiated a nationwide voluntary product recall at the retail level of all lots of baby wipes that it manufactured under the brand names Cuties, Diapers.com, Femtex, Fred’s, Kidgets, Member’s Mark, Simply Right, Sunny Smiles, Tender Touch, and Well Beginnings, because some packages may contain bacteria. These wipes were distributed by Nutek prior to October 21, 2014 to the following retail stores: Walgreens, Sam’s Club, Family Dollar, Fred’s, and Diapers.com.
After receiving a small number of complaints of odor and discoloration, Nutek conducted microbial testing that showed the presence of a bacteria, called Burkholderia cepacia (B. cepacia), in some of these products. Soon after, on October 3, 2014 the company initiated a voluntary withdrawal of lots that had tested positive for the bacteria, as well as other baby wipes in the surrounding time frame. After some additional lots were tested, as a precautionary measure, Nutek believed it was a prudent decision to withdraw all its baby wipe products.
- B. cepacia poses little medical risk to healthy people. However, people who have certain health problems like weakened immune systems or chronic lung diseases, particularly cystic fibrosis, may be more susceptible to infections with B. cepacia. If you believe you have a weakened immune system or chronic lung disease and you have used one of the affected wipe products, you should call your doctor promptly for medical advice.
As of October 3, 2014, the date of the original withdrawal, the company had received only one report of irritation. Numerous reports of complaints have since been received by the company that include rash, irritation, infections, fever, gastro-intestinal issues, and respiratory issues, though these reports have not been confirmed to be related to the use of these products.
The company has not identified the cause of the problem, but is continuing to investigate. In the interim, Nutek has stopped shipping baby wipes manufactured at the facility.
Nutek takes the safety of consumers and the quality of its products very seriously and is taking all appropriate steps to address the issue and ensure this does not happen again.
The company is working with the U.S. Food & Drug Administration and the affected retailers and distributors throughout this process to address the issue.
COMMENT:
An article called “Burkholderia cepacia: The Decision is Overdue” was written by Torbeck et al in October 2011. Within this article they discuss B. cepacia and the various microbiological problems that may be encountered within medical devices and drugs. They note that water sources remain an excellent source of the bacterium which may survive in water for weeks, but only days on solid surfaces.
Within the Recall the Company (Nutek) had not identified the cause of the problem, but was continuing to investigate. I would encourage Nutek to review this article from 2011 and consider the following potential causes that they list.
They include:
- Inadequate cleaning procedures
- Use of unsuitable grade of water (g., use of potable water to clean the process equipment)
- Poor water system control (g., lack of proper sanitization, failure to validate and lack of scheduled maintenance)
- Poor water systems design (g., stagnant water allowed biofilm development
- Inadequate testing and specification (e.g., inadequate microbiological analysis, contaminated raw materials, incomplete/incorrect testing for antimicrobial effectiveness)
The authors proceed to indicate that water was implicated within six recalls, while contaminated raw materials were implicated three recalls and inadequate testing before distribution was implicated in two recalls.
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