header”></head>

<body class=

FDA Alerts

safety alerts

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 »
  • BD Vacutainer Blood Collection Tubes: Class I Recall

    BD Vacutainer Blood Collection Tubes by Becton, Dickinson and Company (BD): Class I Recall – Chemical Interference with Certain Tests ISSUE: BD is recalling their Vacutainer EDTA Blood Collection Tubes with lavender, tan, pink and green rubber tube stoppers due to a chemical in the rubber tube stopper that interferes with the accuracy of the […]Read More »
  • Riomet – Metformin Hydrochloride Oral Solution

    Riomet (Metformin Hydrochloride Oral Solution): Recall – Microbial Contamination ISSUE: Sun Pharmaceutical Industries is recalling two lots of Riomet (Metformin Hydrochloride Oral Solution), which were found to be contaminated with Scopulariopsis brevicaulis. Use of the affected Riomet potentially could result in a risk of infection, especially in the immunocompromised patient. The most plausible portal of […]Read More »
  • Diabetes Infusion Sets by Medtronic

    Recall – Vent Membrane May be Susceptible to Being Blocked by Fluid See the FDA Safety Alert ISSUE: Medtronic is informing patients worldwide of a voluntary recall of specific lots of infusion sets used with all models of Medtronic insulin pumps. The recall is related to a certain discontinued component in these infusion sets and does not […]Read More »