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Metal on Metal Hip Implants Updated Safety Recommendations
Metal-on-Metal Hip Implants: Safety Communication – Updated Safety Recommendations AUDIENCE: Orthopaedic surgery, Radiology, Risk Manager ISSUE: FDA notified healthcare professionals that it is...
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Rugby Natural Iron Supplement Recall
Ferrous Sulfate Tablets, 325 mg Labeled as Rugby Natural Iron Supplement: Recall – Bottle May Contain Meclizine HCl 25 mg Tablets AUDIENCE: Pharmacy, Consumer ISSUE: Advance Pharmaceutical Inc....
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Bausch and Lomb 27G Sterile Cannula Class I Recall
Bausch and Lomb 27G Sterile Cannula Packed in Amvisc and Amvisc Plus Ophthalmic Viscosurgical Devices (OVD): Class I Recall – Cannulas May Leak or Detach From the Syringe includes Bausch and Lomb 27G...
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Samsca tolvaptan Drug Warning
Samsca (tolvaptan): Drug Warning – Potential Risk of Liver Injury AUDIENCE: Gastroenterology, Nephrology, Pharmacy ISSUE: Otsuka and FDA notified healthcare professionals of significant liver injury...
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Lactated Ringers and 5 Percent Dextrose Injection Recall
Lactated Ringers and 5 Percent Dextrose Injection, USP, 1000 ML, Flexible Containers: Recall – Due to Non-Sterility AUDIENCE: Pharmacy, Patient, Health Professional ISSUE: Hospira, Inc. is initiating a...
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Vycor Viewsite Brain Access System VBAS Class 1 Recall
Vycor Viewsite Brain Access System (VBAS): Class 1 Recall – Unidentified Fiber Found on Device AUDIENCE: Neurology, Surgery, Risk Managers ISSUE: Vycor Medical recalled its VBAS because an...
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Hamilton Medical Inc HAMILTON T1 Ventilators
Hamilton Medical, Inc., HAMILTON-T1 Ventilators with Software Versions 1.1.2 and Lower AUDIENCE: Anesthesiology, Risk Managers ISSUE: During ventilation of small pediatric patients with high airway...
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AMPLATZER TorqVue FX Delivery System Class I Recall
St. Jude Medical, AMPLATZER TorqVue FX Delivery System: Class I Recall – Core Wire May Fracture AUDIENCE: Risk Manager, Surgery, Cardiology ISSUE: FDA notified healthcare professionals of a Class I...
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Giraffe and Panda T-Piece Masks Resuscitation Systems Class 1 Recall
GE Healthcare, LLC, Giraffe and Panda T-Piece Resuscitation Systems and Mask Resuscitation Systems: Class 1 Recall – Potential Reversal of Oxygen/Air AUDIENCE: Risk Managers, Pulmonology ISSUE: The...
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Gilead Vistide Cidofovir Injection Recall
Vistide (Cidofovir Injection) by Gilead: Recall – Presence Of Particulate Matter AUDIENCE: Pharmacy, Patient, Health Professional ISSUE: Gilead Sciences, Inc. is voluntarily recalling lot B120217A of...
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DePuy Orthopaedics LPS Diaphyseal Sleeve Class I Recall
DePuy Orthopaedics LPS Diaphyseal Sleeve: Class I Recall – Taper Connection May Not Accommodate Physiologic Loads AUDIENCE: Orthopedics, Surgery, Risk Manager ISSUE: FDA notified healthcare...
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Omontys peginesatide Injection by Affymax and Takeda Recall
Omontys (peginesatide) Injection by Affymax and Takeda: Recall of All Lots – Serious Hypersensitivity Reactions AUDIENCE: Patients, Healthcare Professionals, Hematology ISSUE: Affymax, Inc. and Takeda...
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Lumenis VersaCut Tissue Morcellator Class 1 Recall
Lumenis VersaCut Tissue Morcellator: Class 1 Recall – Labeling Correction – Potential For Air Embolisms To Occur If Tubing Is Hooked Up Backwards AUDIENCE: Biomedical Engineering, Risk Managers,...
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Sensipar Cinacalcet Hydrochloride Drug Safety Communication
Sensipar (Cinacalcet Hydrochloride): Drug Safety Communication – FDA Suspends Pediatric Clinical Trials After Report Of Death AUDIENCE: Health Professional, Endocrinology, Pediatrics ISSUE: FDA has...
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Ad-Tech Macro Micro Subdural Electrodes Recall
Ad-Tech Macro Micro Subdural Electrodes Audience: Risk Manager, Biomedical Engineering, Neurosurgery ISSUE: FDA and Ad-Tech notified healthcare professionals of a Class 1 recall due to concern the...
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Azithromycin Zithromax or Zmax Drug Safety Communication
Azithromycin (Zithromax or Zmax): Drug Safety Communication – Risk of Potentially Fatal Heart Rhythms AUDIENCE: Family Practice, Patient, Pharmacy, Health Professional ISSUE: FDA is warning the public...
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February 2013 Safety Labeling Changes
The MedWatch February 2013 Safety Labeling Changes posting includes 35 products with safety labeling changes to the following sections: BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE...
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Incretin Mimetic Drugs for Type 2 Diabetes
Incretin Mimetic Drugs for Type 2 Diabetes: Early Communication – Reports of Possible Increased Risk of Pancreatitis and Pre-cancerous Findings of the Pancreas AUDIENCE: Gastroenterology,...
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Neptune 1 Silver and Neptune 2 Ultra Safety Communication
Stryker Instruments Neptune 1 Silver and Neptune 2 Ultra Waste Management System (Neptune 1 Silver and Neptune 2 Ultra): Safety Communication – Reports of Serious Tissue Damage and Patient Death...
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Med Prep Consulting Compounded Products Recall
Med Prep Consulting Inc. Compounded Products: Recall – Potential Mold Contamination AUDIENCE: Risk Manager, Pharmacy, Family Practice ISSUE: Med Prep Consulting, Inc. notified the public that it is...
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