Baby Wipes Recalled Due to Bacterial Contamination

 A PA firm is recalling baby wipes after tests showed that the product contains Burkholderia cepacia. This gram negative bacteria is considered more of a secondary pathogen in that it only causes infection in individuals with underlying health issues, especially those in hospitals. According to the CDC, B. cepacia is a hardy organism in that it is more resistant to common antibiotics. It has also been found to be more resistant to antiseptics. This might be a reason why it was found in this product, and is also a good reason for conducting a recall in that it will have exposure to a high risk group...babies.

FDA Recall Noticehttp://www.fda.gov/Safety/Recalls/ucm420426.htm
Nutek Disposables, Inc. Issues Alert Due to Potential Bacteria in Baby Wipes

Contact:
Consumer: 1-855-646-4351
Media: Sean Wood 1-212-445-8310
swood@webershandwick.com
Hallie Bozzi 1-212-445-8276 hbozzi@webershandwick.com

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.

Consumers who have purchased this product can return it to the place of purchase for a full refund. Consumers with questions may contact the company at 1-855-646-4351, Monday through Friday, 10 AM – 4 PM EDT.

Brand NameRetailerLot Numbers of Product Manufactured by Nutek
Cuties Internet and various retailers All Lots
Diapers.com Diapers.com All Lots
Femtex Family Dollar All Lots
Fred's Fred's All Lots
Kidgets Family Dollar All Lots
Member's Mark Sam's Club All Lots
Simply Right Sam's Club All Lots
Sunny Smiles Walgreens All Lots
Tender Touch Various retailers All Lots
Well Beginnings* Walgreens Certain Lots±
*These lot numbers represent all lots manufactured by Nutek. There may be other lots that are made by manufacturers other than Nutek and that are not subject to this recall.



USA Today Network
http://www.usatoday.com/story/news/nation-now/2014/10/28/baby-wipes-recalled-bacteria/18044737/
Baby wipes recalled over possible bacterial contamination
Jolie Lee, USA TODAY Network 9:17 a.m. EDT October 28, 2014

Ten brands of baby wipes are part of a nationwide voluntary recall after tests showed the presence of a bacteria in some of these products.

Nutek Disposables recalled the following brands:
• Cuties
• Diapers.com
• Femtex
• Fred's
• Kidgets
• Member's Mark
• Simply Right
• Sunny Smiles
• Tender Touch
• Well Beginnings

The wipes were sold at Walgreens, Sam's Club, Family Dollar, Fred's and Diapers.com.

Nutek had received "a small number of complaints of odor and discoloration," according to a Nutek statement.

The company tested the wipes and found a bacteria called Burkholderia cepacia (B. cepacia), in some of these products, the statement said.

B. cepacia poses little threat to healthy people, according to the Centers for Disease Control and Prevention. But it can be harmful to people with weakened immune systems, especially cystic fibrosis, according to the CDC.

The company hasn't determined the cause of the problem, and has stopped selling baby wipes manufactured at the facility, Nutek said in the statement.

Consumers who have purchased this product can return it to the place of purchase for a full refund. They can also call the company at 1-855-646-4351, Monday through Friday, 10 a.m. to 4 p.m. ET