PMA Final Decisions for April 2011

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Class I Medical Device Recall: Oridion Medical and Philips Healthcare Microstream CO2 Filterline (FilterLine H Set Infant/Neonate, VitaLine H Set Infant/Neonate)

Recall Class: Class I Date Recall Initiated: April 7, 2011 Product: Microstream CO2 Filterline (FilterLine H Set Infant/Neonate, VitaLine H Set Infant/Neonate) Affected models and lots: The affected devices were manufactured and distributed between October 2010 and February 2011. Use: The Microstream CO2 Filterline is a medical device used by emergency medical services, hospitals, and…

Guidance for Industry and Food and Drug Administration Staff – Assembler's Guide to Diagnostic X

Document issued on: May 17, 2011 This document supersedes Assembler’s guide to diagnostic x-ray equipment: responsibilities of assemblers, distributors, and dealers of diagnostic x-ray equipment under the federal performance standard (DHHS Publication FDA 81-8144, November 1980) For questions regarding this document contact Sean Boyd at 301-796-5710 or via email at [email protected]. U.S. Department of Health…

Aidapak Services Repackaged Pharmaceuticals: Recall

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