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Safety Alerts2018-05-21T19:56:29+00:00

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FDA Alerts

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Safety Alerts

  • HeartMate 3™ Left Ventricular Assist System: Class I Recall

    HeartMate 3™ Left Ventricular Assist System: Class I Recall – Due to Potential Malfunction that may Lead to Graft Occlusion The class I recall is due to a malfunction in the device’s outflow graft assembly that may cause the outflow graft to twist and close up (occlusion) over time. Occlusion of the outflow graft can […]Read More »
  • Class 2 Device Recall 2008 Series Hemodialysis Machine

    Class 2 Device Recall 2008 Series Hemodialysis Machine Fresenius Medical Care Renal Therapies is recalling its dialyzer, high permeability with or without sealed dialysate system, 2008 K2 Hemodialysis Machine with software version 5.40, Models: (1) Hemodialysis SYS OLC/Diasafe PLS 190610, UDI 00840861100859 (+Serial Number), (2) Machine Short Cap, OLC.DP HP 190630, UDI 00840861100866 (+Serial Number) […]Read More »
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