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Alcohol Prep Pad Recalls Issued Over Sterility Concerns

Two recalls have been issued for certain alcohol prep pads distributed nationwide, due to a risk that they may be contaminated and pose a risk of infection for users. 

The FDA announced two medical alcohol prep pad recalls over the last several days, both involving products distributed by Simple Diagnostics and manufactured by Foshan Flying Medical Products Co. Ltd.

The alcohol prep pad recalls came after the manufacturing company recognized the potential for the products to contain bacteria and lack sterility. To date, no injuries or illnesses have been reported in relation with the recalls.

The first Simple Diagnostic recall was announced on November 30, with the second Pharmacist Choice Alcohol Prep Pad recall issued on December 5.

Simple Diagnostics first learned of the issue after receiving notice from the Chinese manufacturing company that three lots of the alcohol pads may contain bacteria or lack sterile assurances.

Alcohol prep pads are typically used by health care professionals and patients for preparation of the skin prior to an injection, as well as in first aid to decrease germs in minor cuts, scrapes, and burns. The use of a non-sterile alcohol prep pad could result in mild to severe adverse health consequences depending on the nature of the bacteria present.

Contaminated alcohol pads could cause problems ranging from minor skin infection to more serious and potentially life-threatening infections. The alcohol wipes could place the bacteria on the skin, which may then be pushed into the body by the needle. Individuals with suppressed immune systems or those undergoing surgery may be particularly at-risk of problems from the alcohol prep pads.

The recalls include Alcohol Prep Pads with UPC number 898302001050 and NDC number 98302-0001-05. The specific lots contain the lot codes SD2070421201 with a December 2019 expiration date, SD2070420925 with a September 2019 expiration date, and SD2070420601 with a December 2019 expiration date.

The recalled units were manufactured in China under Foshan Flying Medical Products Co. Ltd., where they were distributed to Simple Diagnostic for distribution throughout the U.S. from October 18, 2016 through July, 19, 2017.

This is the second time this year Foshan Flying Medical alcohol prep pads have been linked to sterility problems. In September, the FDA issued a warning to consumers not to use the company’s products.

The FDA initially contacted Foshan on May 25, 2017 over quality control problems. After repeated follow-up meetings, the FDA claims Foshan refused to issue a recall.

All products made by Foshan were placed on an import alert on May 23, 2017, to stop the alcohol prep pads and antiseptic towelettes from entering the country. The agency also issued a warning letter to Foshan on August 1, regarding violations of “current good manufacturing practice regulations.”

Customers with recalled alcohol prep pads are being asked to stop using them immediately and contact Simple Diagnostics at 1-877-342-2385. Simple Diagnostics announced it has begun sending notification letters to its customers and distributors with instructions on how to arrange the return of all products.

In January 2011, alcohol prep pad manufacturer, Triad Group, announced a recall of over 10 million medical sanitary wipes that were sold under a variety of labels, including CVS and Walgreens brands, due to the risk of the packets containing Bacillus cereus infection.

The contaminated prep pads and wipes were linked to at least eight deaths, and were followed by a number of wrongful death lawsuits against the manufacturers.

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