Monthly Archives: August 2012

Automix Automated Nutrition Compounder Systems Class I Recall

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translation servicesTranslate | French translation Spanish translation translate German translate Chinese Baxter Healthcare Corporation, Automix Automated Nutrition Compounder Systems: Class I Recall – Risk of Fluid Entry into Device Keypads AUDIENCE: Risk Manager, Pharmacy ISSUE: FDA notified healthcare professional of … Continue reading

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CareFusion 303 Alaris Pump Module Model 8100 Class I Recall

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translation servicesTranslate | French translation Spanish translation translate German translate ChineseCareFusion Alaris Pump Module Model 8100: Class I Recall – Motor Stalls During Infusion [Posted 08/24/2012] AUDIENCE: Risk Manager, Biomedical Engineering ISSUE: FDA notified healthcare professionals and their medical care … Continue reading

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Reumofan Plus Recall

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translation servicesTranslate | French translation Spanish translation translate German translate ChineseReumofan Plus: Recall – Undeclared Drug Ingredient [UPDATED 08/21/2012] FDA is issuing an updated alert that Reumofan Plus and Reumofan Plus Premium contain undeclared active ingredients found in prescription drugs … Continue reading

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Synthes Hemostatic Bone Putty Class I Recall

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translation servicesTranslate | French translation Spanish translation translate German translate ChineseSynthes Hemostatic Bone Putty: Class I Recall – Potential for Putty to Ignite [Posted 08/21/2012]   AUDIENCE: Surgery, Risk Manager ISSUE: There is the potential for Hemostatic Bone Putty to … Continue reading

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Hospira Propofol Injectable Emulsion Recall

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translation servicesTranslate | French translation Spanish translation translate German translate Chinese  Hospira Propofol Injectable Emulsion: Recall- Glass Vial Defect [Posted 08/16/2012]  AUDIENCE: Risk Manager, Pharmacy ISSUE: Hospira and FDA notified healthcare professional of a nationwide recall of three lots of … Continue reading

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St Jude Medical Riata Implantable Cardioverter Defibrillator ICD Leads

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translation servicesTranslate | French translation Spanish translation translate German translate Chinese  St. Jude Medical Riata Implantable Cardioverter Defibrillator (ICD) Leads: Safety Communication – Premature Insulation Failure [Posted 08/16/2012]   AUDIENCE: Cardiology, Radiology, Surgery, Family Practice ISSUE: The Food and Drug Administration (FDA) … Continue reading

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Hydromorphone Injection Carpuject Recall

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translation servicesTranslate | French translation Spanish translation translate German translate Chinese  Hospira Hydromorphone Hydrochloride Injection 2 MG/ML, 1 mL fill in 2.5 mL Carpuject: Recall- May Contain More Than The Intended Fill Volume   Audience: Risk Manager, Pharmacy Issue: Hospira … Continue reading

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Covidien Shiley Adult Tracheostomy Tubes Class I Recall

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translation servicesTranslate | French translation Spanish translation translate German translate ChineseCovidien Shiley Adult Tracheostomy Tubes: Class I Recall – Reports Of Volume Leakage And/or Disconnection Between The Inner And Outer Cannulae AUDIENCE: Consumer, Health Professional, Home Care ISSUE: FDA notified … Continue reading

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Codeine Use in Certain Children Drug Risks

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translation servicesTranslate | French translation Spanish translation translate German translate ChineseCodeine Use in Certain Children After Tonsillectomy and/or Adenoidectomy: Drug Safety Communication – Risk of Rare, But Life-Threatening Adverse Events or Death AUDIENCE: Pediatricians, Surgery, Consumer ISSUE: The FDA is … Continue reading

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MedWatch July 2012 Safety Labeling Changes

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translation servicesTranslate | French translation Spanish translation translate German translate ChineseThe MedWatch July 2012 Safety Labeling Changes posting includes 41 products with safety labeling changes to the following sections: BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS and PATIENT PACKAGE INSERT. … Continue reading

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Posted in FDA 2012, FDA Label Change, FDA Safety Communication | Tagged , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , | Comments Off on MedWatch July 2012 Safety Labeling Changes