BD Expands Voluntary Recall of ChloraPrep™ 3 mL ... | 合法醫療器材資訊網

2021年3月24日—Sincetheapplicatorisusedforsitepreparationpriortoaninvasiveprocedure,acontaminatedapplicatorcanresultindirectinoculationof ...

BD Expands Voluntary Recall of ChloraPrep™ 3 mL Applicator Nationwide to Include All U.S. States

FRANKLIN LAKES, N.J. (March 24, 2021) – BD (Becton, Dickinson and Company), a leading global medical technology company, has revised its press release dated March 19, 2021 relating to an expanded voluntary 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. S...