Recall Class: Class I Date Recall Initiated: January 23, 2009 Product: Abacus Total Parenteral Nutrition (TPN) Calculation Software Catalogue Numbers: 8300-0045: Abacus Calculator Only (Abacus CE) 8300-0046: Abacus Single Work Station (Abacus SE) 8300-0047: Abacus Multi-Work Station (Abacus ME) Use: The Abacus TPN Calculating Software is an FDA Class I Laboratory Information Management System (LIMS)…
Dialysate Concentrates Used in Hemodialysis: Safety Communication
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Baxa Corporation Abacus Total Parenteral Nutrition (TPN) Calculation Software: Class I Recall
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FDA Safety Communication: Dialysate Concentrates and Alkali Dosing Errors with Hemodialysis
Date Issued: May 25, 2012 Audience: Health care professionals using dialysis equipment and prescribing dialysate concentrates, including nephrologists, nurses, and dialysis technicians Hospital and clinic administrators, medical officers, risk managers, and dialysis clinics Medical Specialty: Nephrology Product: All Hemodialysis Dialysate Concentrates Containing Acetate, Acetic Acid, or Citrate. Dialysate is a solution prescribed by physicians for…
Franck’s Compounding Pharmacy Sterile Preparations: Reports of Fungal Endophthalmitis, Expanded Recall
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Meeting materials posted for May 24, 2012 Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting
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CDRH Learn (New Module
Listed below are the courses CDRH currently offers. Additional online courses are being developed and will be posted upon completion. Course List Overview of Regulatory Requirements: Medical Devices [Updated! 11/29/2011] Guidance Documents and Standard Operating Procedures (SOPs) [Updated! 04/10/2012] Premarket Notification Process – 510(k) Investigational Device Exemption Process – IDE [Updated! 2/23/2012] Bioresearch Monitoring (BIMO)…
Hospira Carpuject Pre-filled Cartridges
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Public Meeting
The Food and Drug Administration (FDA) is announcing a public Meeting entitled “Clinical Study Design and Performance of Hospital Glucose Sensors.” The purpose of the meeting is to discuss clinical study design considerations and performance metrics for innovative glucose sensors intended to be used in hospital point of care settings. Date, Time and Location Federal…
West Coast Nutritionals Dietary Supplement Products: Recall
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