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Cracks, Gaps In Pentax Duodenoscopes Prompt Company, US FDA Safety Communications

Executive Summary

Pentax Corp. sent out a field correction on Jan. 16, and FDA followed up with a safety communication the next day, warning that cracks and gaps in the company's ED-3490TK duodenosopes could increase risks of patient microbial infections, unless appropriate reprocessing instructions are followed closely.

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