TOPIC: Specific Lots of ChloraPrep Clear Single Sterile 1 mL and FREPP Clear 1.5 mL Applicators by BD: Recall - Due to Microbial Contamination
AUDIENCE: Consumer, Patient, Health Care Professional, Pharmacy, Dermatology, Laboratory and Laboratory Personnel
ISSUE: BD is recalling lot 4032183 of ChloraPrep Clear 1 mL Single Sterile and lot 4073005 of FREPP Clear 1.5 mL applicators with paper lidding due to fungal contamination under certain environmental conditions allowing the growth of Aspergillus penicillioides.
These two impacted lots were shipped to distributors and hospitals between March 2024 through June 2024.
Risk Statement: Contamination of skin preparation products with Aspergillus penicillioides may lead to serious systemic infection, sepsis, illness, and death. If the fungus is introduced in the patient’s bloodstream during placement of an intravascular catheter, the catheter would most likely have to be removed, necessitating another procedure. Aspergillus penicillioides infection of a surgical site may result in the need for medical and surgical interventions and long-term treatment with antifungal drugs.
As of today, BD has not received any reports of adverse events related to this recall.
For more information about this recall, click on the red button "Read Recall" below.
BACKGROUND: The products being recalled are used for the preparation of the patient’s skin prior to procedures, to help reduce bacteria that potentially can cause skin infection.
RECOMMENDATIONS:
-
Consumers and distributors should immediately discontinue use of and destroy all affected units in accordance with their facility’s process.
-
BD will issue replacement for destroyed product of the affected lot numbers to consumers that purchased the affected product directly from BD, following receipt of the completed Customer Response Form.
-
Consumer inquiries related to this recall, as well as adverse reaction/events experienced with the product, should be addressed to BD’s North American Regional Complaint Center: 1-844-823-5433 or by emailing: productcomplaints@bd.com.
|
