BD ChloraPrep Applicator Recall Expanded Nationwide Due To Microbial Contamination Risk

Federal health officials have announced an expanded recall for BD ChloraPrep applicators, due to a risk that additional versions of the surgical skin sanitation products may be contaminated, potentially exposing patients to infections and serious injuries.

The FDA announced the BD ChloraPrep applicators recall expansion on March 24, after the manufacturing company identified additional products distributed throughout the U.S. that may have been stored at inappropriate temperatures and under high humidity, potentially allowing the growth of Aspergillus penicillioides.

The products impacted by the recall include ChloraPrep applicators used to apply a sanitation solution directly to the patient’s skin to clean before a surgical procedure.

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

Becton, Dickinson and Company (BD) issued the first ChloraPrep recall on June 23, 2020,  after identifying the cap of the bottled solution may allow fungal contamination to grow under certain environmental conditions.

However, BD has determined additional products distributed under similar packaging could be subject to possible fungal contamination growth if the products are exposed to temperatures of 86 degrees Fahrenheit or 75% relative humidity for more than six months.

The expansion specifically names ChloraPrep® One-Step 3 mL Applicator Clear with catalog number 260400, ChloraPrep® One-Step 3 mL Applicator Hi-Lite Orange with catalog number 260415, BD ChloraPrep™ Clear 3 mL Applicator with catalog number 930400, and BD ChloraPrep™ Hi-Lite Orange™ 3 mL Applicator with catalog number 930415 as being added to the recall.

On March 15, the FDA recommended BD expand the recall to include all unexpired ChloraPrep 3 mL applicators in the United States. However, after BD failed to act upon the FDA’s request, the agency subsequently released a safety warning on March 19, recommending health providers to stop using ChloraPrep skin sanitation applicators due to a risk of microbial contamination.

The agency warned the products are commonly used on a patient’s skin where intravenous catheters are introduced which could potentially introduce the infection into a patient’s bloodstream, likely requiring the catheter to be removed, prolonging or preventing required medical procedures.

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.