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Warning Letter Roundup & Recap – November 24 & December 1, 2015

This article was originally published in The Gray Sheet

Executive Summary

Manufacturer WalkMed dinged for problems with its Triton infusion pumps, and the firm distributed potentially flawed Triton FP pumps; Panoramic Rental didn't report a field correction to FDA after it asked customers to add a warning sticker to its dental X-ray machines; and more. Three device warning letters were listed by FDA last week; one was listed this week.






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