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Percussionaire Corporation issues updated instructions for ventilator tubes due to design defect that could cause hypoventilation, respiratory failure
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Ventilator Correction: Philips Issues Correction for Trilogy Evo Platform Ventilators
Philips Trilogy Evo Ventilators may not function as intended if used with certain nebulizers.
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Reconstruction Prosthesis Correction: Stryker Updates Use Instructions for Patient-Fitted TMJ Implants
Stryker is updating use instructions for TMJ Unilateral and Bilateral Implants due to a discrepancy in the positioning of the screw hole.
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FDA Issues Draft Guidance on Genome Editing Safety Standards to Advance Gene Therapy Development
FDA Issues Draft Guidance on Genome Editing Safety Standards to Advance Gene Therapy Development
http://www.fda.gov/news-events/press-announcements/fda-issues-draft-guidance-genome-editing-safety-standards-advance-gene-therapy-development
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Dialysis Catheter Recall: Merit Medical Removes 16F Dual-Valved Splittable Sheath Introducer
The Merit 16F Dual-Valved Splittable Sheath Introducer may not split as intended. This may cause bleeding, embolization, or loss of vessel for future access.
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Anesthesia Workstation Correction: Draeger Issues Correction for Atlan A350 and A350 XL
Draeger corrects the Atlan A350, A350 XL for piston ventilator failures and mechanical ventilation issues due to manufacturing impurities
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FDA Reminds More Than 2,200 Sponsors and Researchers to Disclose Trial Results
FDA Reminds More Than 2,200 Sponsors and Researchers to Disclose Trial Results
http://www.fda.gov/news-events/press-announcements/fda-reminds-more-2200-sponsors-and-researchers-disclose-trial-results
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Early Alert: Convenience Kit Issue from AVID Medical
The adaptor on Namic RA syringes may unwind during use. The resulting loose connection or disconnection may lead to infection, blood loss, or air embolism.
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Ventilator Correction: Baxter Updates Use Instructions for Volara Single-Patient Use Circuits
When the Volara system is used in a home setting, there is a risk for oxygen desaturation or barotrauma if it is used in-line with a ventilator.
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Early Alert: Sizing Catheter Issue from Cook Medical
When the sizing catheters are used during angiographic procedures the marker bands may be at an increased risk of cracking/breakage.