[Posted 11/08/2016] AUDIENCE: Consumer, Pediatrics ISSUE: Ton Shen Health of Chicago, IL, is recalling its Life Rising brand “Side Head Regulator TT” Tablets because they have tested positive for elevated levels of lead for children under the age of 18. Lead is a naturally occurring element which can affect multiple body systems and is particularly…
HeartWare Ventricular Assist Device (HVAD) Pumps by HeartWare Inc.: Class I Recall
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TAH-t Companion 2 Driver System (C2) and Freedom Driver System by SynCardia Systems: Letter to Health Care Providers
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Testosterone and Other Anabolic Androgenic Steroids (AAS): FDA Statement
[Posted 10/25/2016] AUDIENCE: Patient, Endocrinology, Internal Medicine ISSUE: FDA approved class-wide labeling changes for all prescription testosterone products, adding a new Warning and updating the Abuse and Dependence section to include new safety information from published literature and case reports regarding the risks associated with abuse and dependence of testosterone and other AAS. The Anabolic…
HeartWare Ventricular Assist Device (HVAD) Pumps by HeartWare Inc. : Class I Recall
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HeartWare Ventricular Assist Device (HVAD) Pumps by HeartWare Inc.: Class I Recall
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Willy Rusch Tracheostomy Tube Set by TeleFlex Medical: Class I Recall
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Radiation Therapy Devices by Multidata Systems International: Discontinue Use – Concerns about Risks to Patients
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Medtronic Neurovascular Products: Recall
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Skintact DF29N Multi-function Defibrillation Electrodes by Leonhard Lang: Class I Recall
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