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Tag Archives: FDA recall
Atriphen dietary supplement Xymogen brand Recall
Translation Atriphen dietary supplement (Xymogen brand): Recall – Potential Allergic Reaction Due to Milk and Soy AUDIENCE: Consumer, Health Professional ISSUE: The nutraceutical company, Xymogen, (Orlando, FL) and FDA, are notifying consumers and health professionals of the recall of Atriphen, a … Continue reading
Posted in Consumer Products, FDA 2013, FDA Recall, Healthcare Professionals
Tagged Atriphen, Atriphen dietary supplement Xymogen brand Recall, dietary supplement, drug risks, FDA recall, Recall, Xymogen brand
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Maquet SERVO-i Ventilator Battery Module Class 1 Recall
TranslationMaquet SERVO-i Ventilator Battery Module: Class 1 Recall – Battery Run Time Shorter Than Expected AUDIENCE: Anesthesiology, Biomedical Engineering, Nursing, Risk Managers ISSUE: Some battery modules distributed after Jan. 31, 2010 have a shorter battery run time than expected. This … Continue reading
Posted in Anesthesiology, Biomedical Engineering, FDA 2013, FDA Recall, Nursing, Risk Manager
Tagged Anesthesiology, Battery Module, Biomedical Engineering, Class 1 Recall, Class I Recall, FDA recall, Maquet, Maquet SERVO-i Ventilator Battery Module Class 1 Recall, Nursing, Recall, Risk Managers, SERVO-i Ventilator
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Medtronic DBS NDE Kits Class 1 Recall
TranslationMedtronic: 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
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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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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Newport Medical Instruments Inc HT70 HT70 Plus Ventilators Class I Recall
TranslationNewport Medical Instruments, Inc., HT70 and HT70 Plus Ventilators: Class I Recall – Unit Goes Into Internal Backup Battery Sooner Than Expected AUDIENCE: Risk Manager, Nursing ISSUE: The recall is in response to customer reports of Newport Medical Instrument’s HT70 … Continue reading
Posted in FDA 2013, FDA Recall, Nursing, Risk Manager
Tagged Class 1 Recall, Class I Recall, FDA recall, HT70, Newport Medical Instruments Inc, Newport Medical Instruments Inc HT70 HT70 Plus Ventilators Class I Recall, Nursing, Pharmacy, Plus Ventilators, Recall, Risk Manager, Risk Managers
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Anticoagulant Citrate Phosphate Dextrose Solution USP (CPD) BLOOD-PACK Unit Fenwal Recall
TranslationAnticoagulant Citrate Phosphate Dextrose Solution, USP (CPD) BLOOD-PACK Unit By Fenwal: Recall – Labeling Issue Identified Read the MedWatch Safety Alert, including links to the Recall at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm350275.htm AUDIENCE: Risk Manager, Health Professional, Pharmacy ISSUE: Fenwal has initiated a … Continue reading
Posted in FDA 2013, FDA Recall, Healthcare Professionals, Pharmacy, Risk Manager
Tagged (CPD), Anticoagulant Citrate Phosphate Dextrose Solution, Anticoagulant Citrate Phosphate Dextrose Solution USP (CPD) BLOOD-PACK Unit Fenwal Recall, BLOOD-PACK Unit, Dietary Supplements, drug risks, FDA recall, Fenwal, Health Professional, Pharmacy, Recall, Risk Manager, Risk Managers, USP)
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Piperacillin Tazobactam Injection USP 40.5 grams Recall
TranslationPiperacillin and Tazobactam for Injection, USP 40.5 grams: Recall – Precipitation or Crystallization in IV Bag or IV Line Upon Reconstitution AUDIENCE: Risk Manager, Nursing, Health Professional ISSUE: Apotex Corp. notified healthcare professionals it is conducting, on behalf of the … Continue reading
Posted in FDA 2013, FDA Recall, Healthcare Professionals, Nursing, Risk Manager
Tagged drug risks, FDA recall, Health Professional, Injection, Nursing, Piperacillin, Piperacillin Tazobactam Injection USP 40.5 grams Recall, Recall, Risk Manager, Tazobactam, USP 40.5 grams
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Hospira Inc GemStar Infusion System Recall
TranslationHospira Inc., GemStar Infusion System: Recall – Lithium Battery Low Voltage Models 13000, 13100, 13150, 13086, 13087, 13088 AUDIENCE: Risk Manager, Biomedical Engineering, Nursing ISSUE: Hospira notified healthcare professionals of a Class I recall of the GemStar Infusion System, Models … Continue reading
Posted in Biomedical Engineering, FDA 2013, FDA Recall, Nursing, Risk Manager
Tagged 13086, 13087, 13088, 13100, 13150, Biomedical Engineering, Class 1 Recall, Class I Recall, FDA notice, FDA recall, GemStar Infusion System, Hospira Inc, Hospira Inc GemStar Infusion System Recall, Models 13000, Nursing, Recall
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Eba Multivitamin Supplement Saratoga Therapeutics LLC Recall
TranslationEba Multivitamin Supplement By Saratoga Therapeutics LLC: Recall – Allergy Alert On Undeclared Milk Components AUDIENCE: Consumer, Patient, Health Professional ISSUE: Saratoga Therapeutics, LLC of North Wales, PA recalled 900 bottles of ebA Multivitamin Supplement because they may contain undeclared … Continue reading
Posted in Consumer Products, FDA 2013, FDA Recall, Healthcare Professionals, Patients
Tagged Consumer, Consumer Products, drug risks, Eba Multivitamin Supplement, Eba Multivitamin Supplement Saratoga Therapeutics LLC Recall, FDA recall, FDA warning, Health Professional, Patient, Recall, Saratoga Therapeutics LLC
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Sodium Chloride Injection 0.9 percent USP Hospira Recall
TranslationSodium Chloride Injection 0.9 percent USP, 100 mL Flexible Containers by Hospira: Recall – Particulate Matter AUDIENCE: Pharmacy, Patient, Health Professional ISSUE: Hospira notified the public that last August it initiated a voluntary nationwide user-level recall of one lot of … Continue reading
Posted in FDA 2013, FDA Recall, Healthcare Professionals, Patients, Pharmacy
Tagged 09 percent USP, 100 mL Flexible Containers, drug risks, FDA recall, Health Professional, Hospira, Hospira Recall, Patient, Pharmacy, Recall, Sodium Chloride Injection, Sodium Chloride Injection 09 percent USP 100 mL Flexible Containers
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