Class I Medical Device Recall: Halyard Health, KimVent* Microcuff* Subglottic Suctioning Endotracheal Tubes

Recall Class:  Class I Date Recall Initiated: November 17, 2014 Devices: KimVent* Microcuff* Subglottic Suctioning Endotracheal Tubes See Affected Product Codes and Lot Numbers: KimVent* Microcuff* Subglottic Suctioning, Endotracheal Tube, 7.0 mm KimVent* Microcuff* Subglottic Suctioning, Endotracheal Tube, 7.5 mm KimVent* Microcuff* Subglottic Suctioning, Endotracheal Tube, 8.0 mm KimVent* Microcuff* Subglottic Suctioning, Endotracheal Tube, 8.5…

Class I Medical Device Recall: Nellcor Puritan Bennett, 980 Ventilator System

Recall Class: Class I Date Recall Initiated: October 1, 2014 Devices: Puritan Bennett 980 Ventilator Manufacturing Dates: March 3, 2014 through August 19, 2014 Distribution Dates: March 3, 2014 through August 22, 2014 See list of recalled serial numbers. Use: The Nellcor Puritan Bennett 980 Ventilator System provides constant breathing support for adults, children, and…

Consumer Information on: BRACAnalysis CDx

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Class I Medical Device Recall: Heart Sync, Multi-function Defibrillation Electrodes Will Not Work with Philips FR3 and FRx AEDs

Recall Class: Class I Date Recall Initiated: November 11, 2014 Devices: All lot codes of the following AED electrodes distributed between October 26, 2011 and November 26, 2014 Adult Radiotransparent Electrode Catalog Number C100-PHILIPS Adult/Child Radiotransparent Electrode Catalog Number C100AC-PHILIPS Adult Radiotransparent Electrode Catalog Number T100LO-PHILIPS Radiotranslucent Electrode Catalog Number T100-PHILIPS Adult/Child Radiotranslucent Electrode Catalog…

Emergency Use Authorizations (December 24 – Added LightMix® Ebola Zaire rRT

2014 Ebola Virus Emergency Use Authorization 2013 Coronavirus Emergency Use Authorization (Potential Emergency) 2013 H7N9 Influenza Emergency Use Authorization (Potential Emergency) Historical Information, Termination of Declaration Letters and Additional Information 2013 Coronavirus Emergency Use Authorization (Potential Emergency) On May 29, 2013 Secretary Kathleen Sebelius determined that Middle East respiratory syndrome coronavirus (MERS-CoV) poses a significant…