Category Archives: Risk Manager

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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Nitroglycerin in 5% Dextrose Injection by Baxter Recall

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Nitroglycerin in 5% Dextrose Injection by Baxter: Recall – Particulate Matter AUDIENCE: Risk Managers, Critical Care Medicine, Cardiology ISSUE: Baxter International Inc has initiated a voluntary recall of one lot of Nitroglycerin in 5% Dextrose Injection due to particulate matter … Continue reading

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Spacelabs Anesthesia Workstations and Service Kits Class I Recall

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Spacelabs Healthcare, Inc., Spacelabs Anesthesia Workstations and Service Kits: Class I Recall – Bag-to-Vent Switch in CAS I/II Absorbers May Fail AUDIENCE: Risk Manager, Anesthesiology ISSUE: FDA notified healthcare professionals of a Class I Recall due to a potential defect in … 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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Hospira GemStar Infusion System Class I Recall

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Hospira GemStar Infusion System: Class I Recall – Pressure Sensor Calibration Drift AUDIENCE:  Biomedical Engineering, Nursing, Critical Care Medicine, Home Care, Risk Manager ISSUE: The proximal and distal pressure sensor calibration can drift resulting in the pump failing the Proximal … 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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Baylis Medical TorFlex Transseptal Guiding Sheath Kit Class I Recall

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Baylis Medical TorFlex Transseptal Guiding Sheath Kit: Class I Recall – Sheath Could Remove Particulate AUDIENCE: Cardiology, Risk Manager ISSUE:  FDA notified healthcare professionals of the Class 1 recall of TorFlex Transseptal Guiding Sheath Kit.  The sheath could remove particulate … Continue reading

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Edwards Lifesciences LLC EMBOL X Glide Protection System Class I Recall

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Edwards Lifesciences LLC, EMBOL-X Glide Protection System: Class I Recall – Deformed Cannula Tip AUDIENCE: Risk Manager, Cardiology ISSUE: FDA notified healthcare professionals that Edwards Lifesciences LLC issued a Class I Recall of the EMBOL-X Glide Protection System. The tip … 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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