BD ChloraPrep Applicator Contamination Risk: FDA Advisory
Monday, March 22, 2021
IPSIS Patient Safety Alert 03/22/2021: FDA Advises Health Care Professionals Not to Use
ChloraPrep 3 mL Applicators Manufactured by BD
(Becton, Dickinson and Company)
This is an important alert from the International Pain and Spine Intervention Society. IPSIS sends Patient Safety Alerts when it receives important information regarding products or services that can impact your patients' safety. When the Food and Drug Administration (FDA) issues a safety alert, or a company announces a recall or market withdrawal, the FDA posts the announcement as a public service. In such cases neither IPSIS nor the FDA endorse either the product or the company.
ISSUE: The FDA advises health care professionals not to use ChloraPrep 3 mL applicators manufactured by BD (Becton, Dickinson and Company), due to microbial contamination risks. The drug was distributed globally and is labeled with “CareFusion, El Paso, TX.”
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. Health care professionals should use an available alternative.
The FDA recommended on March 15, 2021, that BD expand their recall (initiated in June 2020) to include all unexpired ChloraPrep 3 mL applicators in the U.S. The company’s limited recall, which covered countries and U.S. territories with tropical climates, was due to the lid defect after a finding of fungal growth that breached the product seal. To date, the company has not taken action to expand their recall and remove additional dangerous drugs from the U.S. market.
RECOMMENDATION: The 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.
The FDA is not aware of any adverse events associated with use of BD’s ChloraPrep 3 mL applicators and encourages health care professionals and patients to report adverse events or quality problems experienced with the use of any medication to FDA’s MedWatch Adverse Event Reporting Program:
- Complete and submit the report online; or
- Download and complete the form, then submit it via fax at 1-800-FDA-0178
Source: Food and Drug Administration - Accessed 03/22/2021
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