Category Archives: FDA 2012

MedWatch December 2012 Safety Labeling Changes

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 The MedWatch December 2012 Safety Labeling Changes posting includes 42 products with safety labeling changes to the following sections: BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS and PATIENT PACKAGE INSERT.   The “Summary Page” provides a listing of drug names … Continue reading

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Praxair Inc Grab n Go Vantage Portable Oxygen Cylinder Class I Recall

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Praxair Inc., Grab ‘n Go Vantage Portable Oxygen Cylinder Units: Class I Recall – Risk of Fire Inside Cylinder Unit AUDIENCE: Risk Manager ISSUE: Praxair Inc. issued a recall of the Grab ‘n Go Vantage Portable Oxygen Cylinder unit because … Continue reading

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GE Healthcare T-Piece Circuits Class I Recall

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GE Healthcare T-Piece Circuits for the Giraffe and Panda Resuscitation Systems: Class I Recall – Failure to Achieve the Desired Inspiratory Pressure During Ventilation AUDIENCE: Emergency Medicine, Pediatrics, Risk Manager ISSUE: The disposable T-piece circuits do not achieve the maximum … Continue reading

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Zimmer Spine PEEK Ardis Inserter Class I Recall

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Zimmer 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

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Ventlab Adult and Pediatric Manual Resuscitators Recall

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Ventlab Adult and Pediatric Manual Resuscitators: Recall-Valve Leak Prevents Flow of Air/Oxygen to Patient Audience: Risk Manager, Anesthesiology ISSUE: The affected manual resuscitators may have a valve leak which prevents the flow of air/oxygen to the patient. This lack of … Continue reading

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Bunnell Life Pulse High-Frequency Ventilator Patient Circuits Recall

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 Bunnell Life Pulse High-Frequency Ventilator Patient Circuits: Recall- Melted Insulation Can Cause Sparking and Smoke   Audience: Risk Manager, Anesthesiology ISSUE: FDA notified healthcare professionals and their provider organizations that this product has been found to have heater wire insulation … Continue reading

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Medtronic Drug Infusion Pumps Recall

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  Medtronic Drug Infusion Pumps: Recall – Intermittent or Permanent Pump Motor Stall  SynchroMed II ImplantableSynchroMed EL Implantable Audience: Risk Manager, Physical Medicine, Neurosurgery ISSUE: FDA and Medtronic notified healthcare professionals that using unapproved drugs with the SynchroMed Infusion Pump … Continue reading

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Hydrocodone Bitartrate and Acetaminophen Tablets 10 mg 500 mg Recall

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Hydrocodone Bitartrate and Acetaminophen Tablets 10 mg/500 mg: Recall – Potential for Oversized Tablets Qualitest/Endo Health Mylan UPDATE 12/21/2012: Mylan announced a voluntary nationwide recall to the retail level of three lots of Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 … Continue reading

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Pradaxa dabigatran etexilate mesylate Drug Safety Communication

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Pradaxa (dabigatran etexilate mesylate): Drug Safety Communication – Should Not Be Used in Patients with Mechanical Prosthetic Heart Valves AUDIENCE: Cardiology, Patient ISSUE: The U.S. Food and Drug Administration (FDA) is informing health care professionals and the public that the … Continue reading

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Xyrem sodium oxybate Drug Safety Communication

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Xyrem (sodium oxybate): Drug Safety Communication – Warning Against Use With Alcohol or Drugs Causing Respiratory Depression AUDIENCE: Neurology, Internal Medicine, Patient ISSUE: FDA reminded healthcare professionals and patients that the combined use of Xyrem (sodium oxybate) with alcohol or … Continue reading

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