BD announced that it revised a previous press release from last week to expand a voluntary recall of its ChloraPrep 3 mL applicator.
Franklin Lakes, N.J.-based BD initiated the recall for specified catalog numbers of the applicator device on June 23, 2020, due to possible fungal contamination under certain environmental conditions, according to a news release.
Storage of the ChloraPrep 3 mL applicator in regions of the world with high heat and humidity may expose the product to temperatures of 30°C (86°F) and 75% relative humidity, allowing the growth of Aspergillus penicillioides.
Growth of the fungus within the packaging can contaminate the applicator’s surface and/or the gloved hands of the healthcare professional using it. Then, consequently, it can contaminate the sterile field.
The applicator is used to prepare a site before an invasive procedure, meaning contamination can result in direct inoculation of the fungus to tissues. However, to date, no complaints, adverse events, injuries or deaths were reported related to the recall.
Serious systemic infection, sepsis, illness and death are potential outcomes of skin preparation products with the fungus. If the fungus is introduced to a patient’s bloodstream during an intravascular catheter placement, the catheter would most likely have to be removed. The patient would need another procedure. The surgical site’s infection may result in further medical and surgical interventions, plus long-term treatment with antifungal drugs.
BD’s recall does not include 3 ml applicators found in kits. It does not include any other ChloraPrep product presentations, as all other ChloraPrep products are manufactured with different packaging materials unaffected by the issue.
The company is implementing a global packaging change for the 3 mL product to correct the issue. BD expects the change to be available by the end of April in the U.S., while implementation in other countries will vary.
BD will notify all customers and distributors about the recall. Users are instructed to discard all remaining inventory of impacted ChloraPrep 3 mL applicators, the lot numbers of which are listed below:
- 260400 – ChloraPrep One-Step 3 mL applicator – Clear
- 260415 – ChoraPrep One-Step 3 mL applicator – Hi-Lite Orange
- 930400 – BD ChloraPrep Clear 3 mL applicator
- 930415 – BD ChloraPrep Hi-Lite Orange 3 mL applicator
