[Posted 03/08/2017] AUDIENCE: Neurology, Surgery, Health Professional, Patient ISSUE: FDA is alerting the public about an experimental procedure called Transvascular Autonomic Modulation (TVAM). This procedure may put patients at risk because is being promoted as treatment for a variety of conditions even though it has not been formally studied in…
SPS-1 Static Preservation Solution distributed by Organ Recovery Systems: Safety Communication – FDA Warns Of Potential Contamination
[Posted 03/09/2017] AUDIENCE: Surgery, Infectious Disease, Transplantation, Risk Manager ISSUE: On Dec. 14, 2016, staff at a health care facility notified the FDA of an uncharacteristic odor from SPS-1 encountered during an organ procurement operation. Laboratory results from fluid samples and cultures from the SPS-1 used for this operation confirmed…
Herbal and Dietary Supplement Products by Regeneca Worldwide: Recall – Not Manufactured in Compliance with Current Good Manufacturing Practices
[Posted 03/09/2017] AUDIENCE: Consumer ISSUE: Regeneca Worldwide, a division of VivaCeuticals, Inc. is conducting a nationwide recall of its entire line of herbal and dietary supplement products pursuant to a Consent Decree entered by the federal court for the Central District of California. This recall applies to all products manufactured…
Lifepak 1000 Defibrillators by Physio-Control: Voluntary Field Action – Immediately Remove and Reinstall Battery
UPDATED 03/09/2017. Recall classified as Class I. Physio-Control has determined that wear and oxidation formation between the battery and device electrical contacts may cause power interruptions. Physio-Control anticipates contacting customers in May 2017, to schedule a hardware device correction for the LIFEPAK 1000 devices, which includes modifying the power control…
SPS-1 Static Preservation Solution distributed by Organ Recovery Systems: Safety Communication
[Posted 03/09/2017] AUDIENCE: Surgery, Infectious Disease, Transplantation, Risk Manager ISSUE: On Dec. 14, 2016, staff at a health care facility notified the FDA of an uncharacteristic odor from SPS-1 encountered during an organ procurement operation. Laboratory results from fluid samples and cultures from the SPS-1 used for this operation confirmed contamination with Pantoea and Enterococcus…
FDA Warns Of Potentially Contaminated SPS-1 Static Preservation Solution Distributed by Organ Recovery Systems, Inc.: FDA Safety Communication
Date Issued: March 9, 2017 Audiences: Organ and tissue procurement organizations Organ and tissue transplantation centers Health Care Providers who conduct organ and tissue transplant procedures Health Care Providers who care for organ and tissue transplant recipients Operating Room Managers, Directors and Staff Risk Managers Patients considering organ or tissue transplantation Organ and tissue recipients…
Balloon angioplasty devices to treat autonomic dysfunction: FDA Safety Communication
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FDA concern over experimental procedures that use balloon angioplasty devices to treat autonomic dysfunction: FDA safety communication
Date issued: March 8, 2017 Audiences: Health care providers who manage the care of patients with autonomic dysfunction, including neurologists, interventionalists (radiologists, vascular surgeons, and neurosurgeons), and clinical researchers People considering treatment options for autonomic dysfunction, including but not limited to Parkinson’s disease, multiple sclerosis (MS), fibromyalgia, multiple system atrophy, postural tachycardia syndrome (POTS), peripheral…
Class I Medical Device Recall: Physio-Control Inc. Recalls LIFEPAK 1000 Defibrillator Due to an Electrical Issue Which May Cause the Device to Shut Down Unexpectedly
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Dietary Supplements for Male Sexual Enhancement by A and H Focal: Recall
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