Category Archives: Healthcare Professionals

HeartStart Automated External Defibrillators AED Philips Healthcare

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HeartStart Automated External Defibrillators (AED) From Philips Healthcare: Safety Communication – Failure Of An Electrical Component That Could Cause AEDs To Fail To Deliver Appropriate Shock AUDIENCE: Risk Manager, Emergency Medicine, Health Professional ISSUE: FDA issues safety communication on HeartStart … Continue reading

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CLR Medicals International Inc Viscoelastic Products Recall

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CLR Medicals International Inc. Viscoelastic Products: Recall – Quality System Deficiencies And Lack Of Premarket Approval (PMR) AUDIENCE: Risk Management, Health Professional ISSUE: CLR Medicals International Inc., initiated a nationwide recall of Viscocel and Viscocel Plus, in response to FDA … Continue reading

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Nature’s Pharmacy and Compounding Center Sterile Compounded Products Recall

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Nature’s Pharmacy and Compounding Center Sterile Compounded Products: Recall – Lack of Sterility Assurance AUDIENCE: Health Professional ISSUE: Nature’s Pharmacy and Compounding Center of Asheville, NC is voluntarily recalling all lots of sterile products compounded by the pharmacy that are … Continue reading

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Medtronic Guidewires Recall

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Medtronic Guidewires: Recall – Potential For Coating On Surface To Delaminate And Detach AUDIENCE: Health Professional, Cardiology, Risk Management ISSUE: Medtronic, Inc.announced that FDA has classified the company’s recently initiated voluntary field action related to certain guidewire. Based on an internal … Continue reading

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Over the Counter Topical Antiseptic Products Drug Safety Communication

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Over-the-Counter Topical Antiseptic Products: Drug Safety Communication – FDA Requests Label Changes and Single-Use Packaging to Decrease Risk of Infection AUDIENCE: Healthcare Professional, Risk Manager, Pharmacy ISSUE: The U.S. Food and Drug Administration (FDA) is requesting label and packaging changes … Continue reading

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OxyElite Pro Dietary Supplements by USP Labs Recall

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OxyElite Pro Dietary Supplements by USP Labs: Recall – Products Linked to Liver Illnesses AUDIENCE: Consumers, Healthcare Professionals ISSUE: The U.S. Food and Drug Administration announced today that USPlabs LLC, of Dallas, Texas, is recalling certain OxyElite Pro dietary supplement … Continue reading

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Perrigo Acetaminophen Infant Suspension Liquid Recall

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Perrigo Acetaminophen Infant Suspension Liquid: Recall – Potential Defect with Co-packaged Oral Syringe   [Posted 11/02/2013] AUDIENCE: Consumer, Patient, Pediatrics, Pharmacy, Health Professional ISSUE: The Perrigo Company announced that it has initiated a voluntary, nationwide product recall to the retail … Continue reading

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MedStream Programmable Infusion Pump Codman and Shurtleff Class 1 Recall

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MedStream Programmable Infusion Pump and Refill Kits by Codman and Shurtleff: Class 1 Recall – Drug Over Infusion AUDIENCE: Risk Manager, Health care Professional ISSUE: FDA and Codman & Shurtleff, Inc. notified healthcare professionals of the class 1 recall of … Continue reading

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Specialty Medicine Compounding Pharmacy Recall

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Specialty Medicine Compounding Pharmacy Certain Unexpired Compounded Sterile Products: Recall – Particulate Matter Found in Vials   AUDIENCE: Pharmacy, Patient, Health Professional   ISSUE:  Specialty Medicine Compounding Pharmacy is voluntarily recalling all lots of certain unexpired human and veterinary sterile … Continue reading

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Engström Ventilator Aespire View Aisys And Avance Anesthesia Machines

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Engström Ventilator, Aespire View, Aisys, And Avance Anesthesia Machines: Voluntary Field Corrective Action – Potential Safety Issue AUDIENCE: Risk Manager, Anesthesiology, Health Professional ISSUE: GE Healthcare has initiated a voluntary field corrective action due to a potential safety issue that … Continue reading

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