ChloraPrep Clear – 1 mL Applicators and ChloraPrep FREPP Clear 1.5 mL Applicators
Product details
- ChloraPrep Clear – 1 mL Applicators and ChloraPrep FREPP Clear 1.5 mL Applicators
Company announcement
BD is voluntarily recalling specific lots of ChloraPrep™ Clear 1 mL Single Sterile and FREPP™ Clear 1.5 mL applicators nationwide due to fungal contamination.
The contamination is caused by Aspergillus penicillioides, which can grow under certain environmental conditions.
These affected lots were distributed to hospitals and distributors between March 2024 and June 2024.
No adverse events, injuries, or deaths have been reported in connection with this recall.
Risk:
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.
Impacted states: Nationwide
Products:
- BD ChloraPrep™ Clear - 1 mL Applicators
- BD ChloraPrep™ FREPP™ Clear 1.5 mL Applicators
Contact
For more information, call 1-844-823-5433 or email productcomplaints@bd.com.