ChloraPrep Applicator Recall Expanded
Saturday, March 27, 2021
IPSIS Patient Safety Alert 03/26/2021: ChloraPrep 3 mL Applicators Manufactured by BD 
(Becton, Dickinson and Company)

 
Recall Expanded Due to Potential Aspergillus Penicillioides Contamination 

 

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: BD has revised
its press release dated March 19, 2021 relating to an expanded recall that was initiated on June 23, 2020 for specified catalog numbers of the ChloraPrep 3 mL applicator due to possible fungal contamination under certain environmental conditions.
BD
has determined that storage of the ChloraPrep 3 mL Applicator in regions of the world with high heat and humidity, where product may be exposed to temperatures of 30 degrees Celsius (86 degrees Fahrenheit) and 75% relative humidity, allows the growth
of aspergillus penicillioides.
The aspergillus penicillioides within the packaging can contaminate the surface of the applicator and/or gloved hands of the health care professional and then consequently the sterile field. Since
the applicator is used for site preparation prior to an invasive procedure, a contaminated applicator can result in direct inoculation of the fungus into tissues.
To date, no complaints, adverse events, injuries, or deaths have been reported
related to this voluntary recall. Click here for more information
about this recall and the affected catalog numbers.
BACKGROUND: 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.
RECOMMENDATION: BD is instructing customers and distributors to discard all remaining inventory of the impacted ChloraPrep 3 mL applicators and is committed
to replacing product affected by the recall.
Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Adverse Event Reporting Program: 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 03/26/2021






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