Medicine recalls
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| The United States: BD announces voluntary worldwide recall for one lot of ChloraPrep™ Clear 1 mL Applicators due to fungal contamination |
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The US Food and Drug Administration (FDA) announces that BD (Becton, Dickinson and Company) today announced the voluntary recall of one lot of ChloraPrep™ Clear 1 mL Applicators (chlorhexidine gluconate 2% w/v; isopropyl alcohol 70% v/v) (lot number: 3200240) due to fungal contamination under certain environmental conditions allowing the growth of Aspergillus penicillioides.
The Aspergillus penicillioides within the packaging can contaminate the surface of the applicator and/or gloved hands of the healthcare 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.
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.
The product is used for the preparation of the patient’s skin prior to surgery, helps to reduce bacteria that potentially can cause skin infection and is packaged in a pouch (1 applicator per pouch, 60 applicators per inner carton). The affected lot was distributed globally beginning in September 2023. To date, there have been no reported customer complaints or adverse events associated with this issue.
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/bd-announces-voluntary-worldwide-recall-one-lot-chlorapreptm-clear-1-ml-applicators-due-fungal
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/Wednesday, Feb 19, 2025
Issued at HKT 15:30
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