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Tag Archives: Surgery
Medtronic DBS NDE Kits Class 1 Recall
Translation Medtronic: Class 1 Recall – Medtronic Deep Brain Stimulation Lead Kit and Activa Dystonia HDE Kit AUDIENCE: Neurology, Nursing, Risk Manager, Surgery ISSUE: Medtronic sent an Urgent Medical Device Correction letter to all affected customers notifying them of the … Continue reading
Posted in FDA 2013, FDA Recall, Neurology, Nursing, Risk Manager, Surgery
Tagged Activa Dystonia HDE, Class 1 Recall, Class I Recall, DBS, Deep Brain Stimulation Lead Kit, FDA recall, Kits, Medtronic, Medtronic DBS NDE Kits Class 1 Recall, NDE, Neurology, Nursing, Recall, Risk Manager, Surgery
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Covidien Surgical Stapler Reloads FDA Safety Communication
Posted in Biomedical Engineering, FDA 2013, FDA Safety Communication, Nursing, Risk Manager, Surgery
Tagged Biomedical Engineering, Covidien, Covidien Surgical Stapler Reloads FDA Safety Communication, FDA Safety Communication, FDA warning, Nursing, Risk Managers, Safety Communication, Surgery, Surgical Stapler Reloads
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Cardinal Health Various Presource Kits Class 1 Recall
TranslationCardinal Health: Class 1 Recall – Various Presource Kits Containing a Pre-Assembled Anesthesia Circuit AUDIENCE: Anesthesiology, Biomedical Engineering, Risk Manager, Surgery ISSUE: Cardinal Health discovered that various Presource Kits containing a pre-assembled anesthesia circuit and filter may contain outer plastic … Continue reading
Posted in Anesthesiology, Biomedical Engineering, FDA 2013, FDA Recall, Risk Manager, Surgery
Tagged Anesthesiology, Biomedical Engineering, Cardinal Health, Cardinal Health Various Presource Kits Class 1 Recall, Class 1 Recall, Class I Recall, FDA recall, Recall, Risk Manager, Surgery, Various Presource Kits
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Stryker Orthopaedics ShapeMatch Cutting Guide Class 1 Recall
TranslationStryker Orthopaedics – ShapeMatch Cutting Guide: Class 1 Recall AUDIENCE: Surgery, Risk Manager ISSUE: FDA notified healthcare professionals of a Class 1 recall for this product due to a software defect that results in wider cutting ranges. The parameters of … Continue reading
Posted in FDA 2013, FDA Recall, Risk Manager, Surgery
Tagged Class 1 Recall, Class I Recall, FDA recall, Recall, Risk Manager, Risk Managers, ShapeMatch Cutting Guide, Stryker Orthopaedics, Stryker Orthopaedics ShapeMatch Cutting Guide Class 1 Recall, Surgery
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Ad-Tech Macro Micro Subdural Electrodes Recall
TranslationAd-Tech Macro Micro Subdural Electrodes Audience: Risk Manager, Biomedical Engineering, Neurosurgery ISSUE: FDA and Ad-Tech notified healthcare professionals of a Class 1 recall due to concern the microelectrodes are defective and may cause injury to the brain. These devices are … Continue reading
Posted in Biomedical Engineering, FDA 2013, FDA Recall, Neurology, Risk Manager, Surgery
Tagged Ad-Tech Macro, Ad-Tech Macro Micro Subdural Electrodes Recall, Biomedical Engineering, Class 1 Recall, Class I Recall, drug risks, FDA recall, Micro Subdural Electrodes, Neurosurgery, Recall, Risk Manager, Surgery
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DePuy Orthopaedics LPS Diaphyseal Sleeve Class I Recall
TranslationDePuy Orthopaedics LPS Diaphyseal Sleeve: Class I Recall – Taper Connection May Not Accommodate Physiologic Loads AUDIENCE: Orthopedics, Surgery, Risk Manager ISSUE: FDA notified healthcare professionals of a Class I recall of the LPS Diaphyseal Sleeve. The LPS Diaphyseal Sleeve … Continue reading
Posted in FDA 2013, FDA Recall, Orthopaedic Surgery, Risk Manager
Tagged Class 1 Recall, Class I Recall, DePuy Orthopaedics, DePuy Orthopaedics LPS Diaphyseal Sleeve Class I Recall, drug risks, FDA recall, LPS Diaphyseal Sleeve, Orthopedics, Pradaxa, Recall, Risk Manager, Surgery
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AMPLATZER TorqVue FX Delivery System Class I Recall
TranslationSt. Jude Medical, AMPLATZER TorqVue FX Delivery System: Class I Recall – Core Wire May Fracture AUDIENCE: Risk Manager, Surgery, Cardiology ISSUE: FDA notified healthcare professionals of a Class I recall of the St. Jude Medical, AMPLATZER TorqVue FX Delivery … Continue reading
Posted in Cardiology, FDA 2013, FDA Recall, Risk Manager, Surgery
Tagged AMPLATZER TorqVue FX Delivery System, AMPLATZER TorqVue FX Delivery System Class I Recall, Cardiology, Class 1 Recall, Class I Recall, FDA recall, Recall, Risk Manager, Surgery
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Vycor Viewsite Brain Access System VBAS Class 1 Recall
Translation Vycor Viewsite Brain Access System (VBAS): Class 1 Recall – Unidentified Fiber Found on Device AUDIENCE: Neurology, Surgery, Risk Managers ISSUE: Vycor Medical recalled its VBAS because an unidentified black fiber was found on the device. This … Continue reading
Posted in FDA 2013, FDA Recall, Neurology, Risk Manager, Surgery
Tagged Brain Access System, Class 1 Recall, Class I Recall, FDA recall, Neurology, Recall, Risk Managers, Surgery, VBAS, Vycor Viewsite, Vycor Viewsite Brain Access System VBAS Class 1 Recall
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Zimmer Spine PEEK Ardis Inserter Class I Recall
TranslationZimmer Spine – PEEK Ardis Inserter: Class I Recall – Risk of Implant Breakage AUDIENCE: Surgery, Risk Manager ISSUE: Zimmer Spine has received reports of the PEEK Ardis Interbody Spacer breaking into fragments when too much lateral force is applied … Continue reading
Posted in FDA 2012, FDA Recall, Risk Manager, Surgery
Tagged Class 1 Recall, Class I Recall, FDA recall, PEEK Ardis Inserter, Recall, Risk Manager, Surgery, Zimmer Spine, Zimmer Spine PEEK Ardis Inserter Class I Recall
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SURGIFLO Hemostatic Matrix Class 1 Recall
TranslationEthicon, Inc., SURGIFLO Hemostatic Matrix and SURGIFLO Hemostatic Matrix Kit Plus FlexTip with Thrombin: Class I Recall – Potential for Packaging Breach AUDIENCE: Risk Manager, Surgery ISSUE: There is an issue within the packing process where a cut could potentially … Continue reading
Posted in FDA 2012, FDA Recall, Risk Manager, Surgery
Tagged Class 1 Recall, FlexTip with Thrombin, Hemostatic Matrix Kit Plus, Risk Manager, Surgery, SURGIFLO, SURGIFLO Hemostatic Matrix, SURGIFLO Hemostatic Matrix Class 1 Recall, SURGIFLO Hemostatic Matrix Kit Plus FlexTip with Thrombin
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