The medical device company BD out of New Jersey issued a recall over the weekend of one lot of their ChloraPrep™ Clear 1 mL Applicators. According to the FDA, the potential for fungal contamination prompted the recall.
BD’s ChloraPrep™ Clear 1 mL Applicators are used by surgeons and health care professionals to sterilize an area of skin on a patient in preparation for a surgery. The active ingredients contained in each applicator are 2% chlorhexidine gluconate and 70% isopropyl alcohol. The National Drug Code for the recalled product is 54365-400-31 with a lot number of 3200240 and a Catalog Number of 930480. The expiration date for the recalled lot is 6/30/2026. Each carton of the product contains 60 applicators, and each case contains four cartons of the product. BD began global distribution of lot 3200240 of their ChloraPrep™ Clear 1 mL Applicators in September of 2023. Distributors and facilities can find the lot and catalog numbers printed on the lid of the product package.
To date, BD has not received any reports of injury or infection linked to the recalled product. The company initiated the voluntary recall after identifying possible contamination of the applicators with the fungus Aspergillus penicillioides. Growth of this particular species of fungi can happen under “certain environmental conditions.” The company has not disclosed how the contamination may have occurred or how it was detected prior to the recall.
Fungal contamination of the recalled product renders the product useless for sterilizing and preparing a patient’s skin prior to surgery. Additionally, presence of Aspergillus penicillioides in the packaging of the ChloraPrep™ Clear 1 mL Applicators could transfer to the gloved hands of the health care professional handling the product, thereby compromising the sterile field. Surgical incision could then transfer the fungal contaminant to the patient’s tissues, putting the patient at risk for “serious systemic infection, sepsis, illness, and death.” The patient may then require additional medical interventions, including prolonged treatment with anti-fungal medications.
BD asks that distributors and health care facilities identify the recalled product, discontinue use of the product, and properly dispose of the product.
Anyone with questions or concerns about the recall can contact BD Monday through Friday from 9 a.m. to 6 p.m. (EST) at 1-844-823-5433 or by email at productcomplaints@bd.com.
Patients and health care providers can report any new adverse health events related to BD’s ChloraPrep™ Clear 1 mL Applicators through the FDA’s MedWatch Online Voluntary Reporting Form.
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