Do Not Use ChloraPrep 3 mL Applicators Due to Microbial Contamination Risk, FDA Warns

Federal health officials are warning health providers to stop using certain ChloraPrep skin sanitation applicators, due to a risk of microbial contamination, which could cause patient injuries and infections.

In a safety warning issued on March 19, the FDA indicates that ChloraPrep 3mL applicators manufactured by Becton Dickson may pose serious infection risks if they become exposed to higher temperatures or humidity.

The ChloraPrep applicators are used to apply a sanitation solution directly to the patient’s skin to clean before a surgical procedure. The FDA issued the warning after the manufacturer refused to recall all potentially affected products.

Becton, Dickinson and Company (BD) issued a ChloraPrep recall on June 23, 2020, impacting certain lots of the product after identifying the cap of the bottled solution may allow fungal contamination to grow under certain environmental conditions. However, it now appears that additional products may pose risks, especially for individuals with compromised immune systems.

According to the initial recall, the manufacturer indicated that if the products are exposed to temperatures of 86 degrees Fahrenheit or 75% relative humidity for more than six months, the solutions container may allow the growth of Aspergillus penicillioides, which is a serious and potentially harmful fungi.  BD indicated the products may have been consistently exposed to these conditions while in storage.

The exposure to Aspergillus penicillioides on the skin, especially for sites being sanitized before surgery, could increase the risk of a patient developing a serious systemic infection, sepsis, illness and death, the FDA warns.

If the infection is introduced into a patient’s bloodstream during the placement of an intravenous catheter, the catheter will likely need to be removed, prolonging or preventing required medical procedures.

On March 15, the FDA recommended BD expand the recall to include all unexpired ChloraPrep 3 mL applicators in the United States. However, since BD has not acted upon this recommendation to date, the FDA is warning healthcare professionals and medical facilities to immediately stop using BD’s ChloraPrep applicators, and to use an alternative sanitation solution.

Customers are being encouraged to report any and all adverse health consequences arising from the use of ChloraPrep 3mL applicators to the FDA’s MedWatch Adverse Event Reporting program by submitting a report online or contacting the agency directly at 1-800-FDA-0178.