Search Results for 'recalls'

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  GE Healthcare Recalls Giraffe Incubators and OmniBeds

  The bedside panels can be upright and look closed but not be securely latched, causing the potential for infants to fall.

  U.S. Food and Drug Administration 12.18.19
  

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• Surgical
  

  J&J's Ethicon Recalls ECHELON FLEX ENDOPATH Staplers

  The staplers are being recalled for failure to completely form staples.

  U.S. Food and Drug Administration 10.31.19
  

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  New Mobile App Notifies Patients, Caregivers and Nurses of Medical Device Recalls

  SoomSafety aims to close the information gap between the FDA, manufacturers, and medical device users.

  PR Newswire 09.06.19
  

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• Cardiovascular | Surgical
  

  Edwards Recalls SAPIEN 3 Ultra Delivery System

  Devices recalled due to burst balloons during surgery, which may result in vascular injury, bleeding, or surgical intervention.

  U.S. Food and Drug Administration 08.22.19
  

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• Software & IT
  

  Fresenius Recalls Volumat MC Agilia Infusion Pump and Vigilant Agilia Drug Library

  Devices were recalled due to a 'Low Priority' 'Keep Vein Open (KVO), End of Infusion' alarm and multiple software errors.

  U.S. Food and Drug Administration 08.13.19
  

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• Cardiovascular
  

  Abbott Recalls Ellipse ICDs

  The ICDs were recalled due to exposed aluminum wires that may prevent defibrillation therapy.

  U.S. Food and Drug Administration 08.05.19
  

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  BD Recalls SmartSite Syringe Administration Set Due to Risk of Leaks

  Leaks could result in under-infusion, delay or interruption, and/or contamination.

  U.S. Food and Drug Administration 07.02.19
  

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• Cardiovascular | Surgical
  

  Terumo Recalls Two Sheaths Over Dislodgment Risk

  The company has acknowledged a potential for the tip to dislodge from the outer rim of the sheath.

  U.S. Food and Drug Administration 05.30.19
  

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  Medical Device Recalls and Units

  Quality issues were responsible for roughly 59 percent of all recalled units.

  Infographics Stericycle

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• Software & IT
  

  Proactive Risk Management to Reduce Recalls in the Life Sciences

  Recalls are serious issues that plague the life sciences industry with many potential negative consequences. They can cost organizations large amounts of time and money, as well as negatively impact brand image and customer trust. At their worst, imp…

  Alexa Sussman, Content Marketing Writer, EtQ 10.12.16
  

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