Category Archives: Surgery

Bard LifeStent Solo Vascular Stent Class 1 Recall

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Bard LifeStent Solo Vascular Stent: Class 1 Recall – Failure to Deploy AUDIENCE: Cardio-vascular Surgery, Interventional Radiology ISSUE: FDA notified health professionals and medical care organizations of a class 1 recall of this product due to deployment issues that range … Continue reading

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Bupivacaine HCL Injection by Hospira Recall

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Bupivacaine HCL Injection 0.25% (2.5 MG/ML) and Bupivacaine HCL 0.75% (7.5 MG/ML), 30 ML Single-Dose Vials by Hospira, Inc.: Recall- Presence of Particulate Matter AUDIENCE: Pharmacy, Anesthesia, Surgery ISSUE: Hospira, Inc. on July 12, 2013, initiated a voluntary nationwide recall … Continue reading

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Cordis Optease Retrievable Inferior Vena Cava IVC Filter Recall

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Cordis Optease Retrievable Inferior Vena Cava (IVC) Filter: Recall – Labeling Correction AUDIENCE: Risk Manager, Cardiology, Surgery ISSUE: Cordis and FDA notified healthcare professionals and their organizations of a product labeling correction to provide clarification and additional information to minimize … Continue reading

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LeMaitre Vascular Inc Albograft Vascular Graft Class I Recall

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LeMaitre Vascular, Inc., Albograft Vascular Graft: Class I Recall – Blood Leak Models: AMC1408, AMC1506, AMC1608, AMC1809, AMC1810, AMC2010, AMC4007, AMC4008, AMC6006, AMC6007, AMC6008, ATC1526, ATC1530, ATC3016, ATC3018, ATC3024, ATC3026, Batch 56890A AUDIENCE: Risk Manager, Cardiology, Surgery ISSUE: LeMaitre Vascular, … Continue reading

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Respironics California Inc Class 1 Recall V60 Ventilators

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Respironics California, Inc. – Class 1 Recall: V60 Ventilators – Issue with software AUDIENCE: Risk Manager, Anesthesiologist, Surgeon ISSUE: Respironics California, Inc. has initiated a recall on the V60 ventilator because of an issue with the software on the V60 … Continue reading

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Symbios GOPump GOBlock Kits Class 1 Recall

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Symbios GOPump and GOBlock Kits: Class 1 Recall – Potential for Excessive High Flow Rates [06/12/2013] AUDIENCE: Surgery, Anesthesia, Risk Managers ISSUE: FDA and Symbios are informing the public of a recallĀ  of all GoPump Rapid Recovery System kits and … Continue reading

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Cook Medical Zilver PTX Drug Eluting Peripheral Stent Class 1 Recall

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Cook Medical, Inc Zilver PTX Drug-Eluting Peripheral Stent: Class 1 Recall – Complaints of Delivery System Tip Separation AUDIENCE: Cardiology, Surgery, Risk Manager ISSUE: Cook Medical received a small number of complaints that the delivery system of the device had … Continue reading

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Medtronic DBS NDE Kits Class 1 Recall

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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 potential … Continue reading

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Covidien Surgical Stapler Reloads FDA Safety Communication

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Cardinal Health Various Presource Kits Class 1 Recall

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Cardinal 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

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