ChloraPrep 3 mL Applicators by BD: CDER Alert – FDA Advises Health Care Professionals Not to Use Due to Microbial Contamination Risks
ISSUE: BD’s investigation confirmed the product’s lid, when exposed to higher temperature and humidity, can fail and lead to microbial contamination which may cause serious infections, especially in patients with compromised immune systems.
BACKGROUND: This drug is used to sanitize skin prior to surgery or catheter procedures.
RECOMMENDATION: FDA advises health care professionals not to use ChloraPrep 3 mL applicators manufactured by BD due to microbial contamination risks. Health care professionals should use an available alternative.