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City Birmington / / Company Boston Scientific Corporation / / Country United States / / Event Product Issues / / Facility Montclair Baptist Medical Center / / IndustryTerm metal / risk devices / reprocessed single-use device / metal jaw-like structures / ethylene oxide gas / predicate device / reprocessed single-use devices / tightly-wound metal coil / semi-critical reprocessed single-use devices / replacement device / metal coil / thin steel wires / chemicals / / MedicalCondition pseudomonas / sterility assurance level / Sterility / modified USP sterility / percent failed sterility / infection / / MedicalTreatment radiation treatment / radiation / / Movie Page 3 II / / Organization Congress / Central Service / FDA’s office of Science and Technology / Association for the Advancement of Medical Instrumentation / Food & Drug Administration / Montclair Baptist Medical Center / FDA / Center for Testing of Medical Products / / Product tissue / / ProvinceOrState Alabama / Maryland / Massachusetts / / Technology alpha / radiation / spectroscopy / / URL www.fda.gov/cdrh/reuse / / SocialTag 
January 2 1,2003 Boston Sclentlflc Corporatlcn One Boston Sclentlfic Place Nattck, MA[removed]Food & Drug Administration