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Medical Procedure Kits Correction: Medline Industries, LP Issues Correction for Medline Craniotomy Kits Containing Codman Disposable Perforators Due to Risk for Device Disassembly

Medline Craniotomy Kits are procedure convenience kits. Kits containing the Codman Disposable Perforator are being corrected by Medline Industries.

http://www.fda.gov/medical-devices/medical-device-recalls/medical-procedure-kits-correction-medline-industries-lp-issues-correction-medline-craniotomy-kits

 
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Continuous Ventilator (Respirator) Correction: Maquet Critical Care AB Updates Use Instructions for Servo Ventilator Systems Due to Risk of Inaccurate Compliance Measurement Leading to Improper Tidal Volume Delivery in Neonatal Patients

Maquet is updating Servo Ventilator instructions due to a risk of inaccurate tidal volume delivery when the extended leak test is used.

http://www.fda.gov/medical-devices/medical-device-recalls/continuous-ventilator-respirator-correction-maquet-critical-care-ab-updates-use-instructions-servo

 
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FDA Requests Sarepta Therapeutics Suspend Distribution of Elevidys and Places Clinical Trials on Hold for Multiple Gene Therapy Products Following 3 Deaths

FDA Requests Sarepta Therapeutics Suspend Distribution of Elevidys and Places Clinical Trials on Hold for Multiple Gene Therapy Products Following 3 Deaths
http://www.fda.gov/news-events/press-announcements/fda-requests-sarepta-therapeutics-suspend-distribution-elevidys-and-places-clinical-trials-hold

 
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Portable Oxygen Concentrator Car Adapter Recall: Drive DeVilbiss Healthcare Removes iGo DV6X-619 DC Car Adapter Due to Cord Possibly Becoming Hot to the Touch and/or Melting While Being Used

Drive Devilbiss Healthcare is recalling iGo2 DV6X-619 DC car adapter due to complaints of the DC power cord being hot to the touch and/or melting while used.

http://www.fda.gov/medical-devices/medical-device-recalls/portable-oxygen-concentrator-car-adapter-recall-drive-devilbiss-healthcare-removes-igo-dv6x-619-dc

 
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BD Issues Update to Voluntary Global Recall of Alaris™ and BD Alaris™ Pump Modules Serviced with Legacy Bezel Kit Assemblies

BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today issued a voluntary recall related to certain Alaris™ and BD Alaris™ Pump Modules that may have been serviced with previously recalled bezel kit assemblies.

http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/bd-issues-update-voluntary-global-recall-alaristm-and-bd-alaristm-pump-modules-serviced-legacy-bezel