Recall Class: Class I Date Recall Initiated: June 1, 2015 Device: Lot numbers: Complete list of affected lot numbers: Right-Sided Endobronchial Tube Left-Sided Endobronchial Tube Double Swivel Accessory Pack Manufactured from: October 2013 to April 2015 Distributed from: October 2013 to May 2015 Devices Recalled in the U.S.: 62,882 Product Codes: 5-15401, 5-16037, 5-16128, 5-16139,…
Public Workshop
The Food and Drug Administration (FDA) is announcing a public workshop entitled “In Vitro Diagnostic Testing for Direct Oral Anticoagulants”. The objective of the workshop is to discuss analytical performance requirements for the diagnostic assessment of direct oral anticoagulants (DOACs), and the clinical circumstances under which patients receiving these agents would require testing. Specifically, this…
PMA Final Decisions for June 2015
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Class I Medical Device Recall: Western/Scott Fetzer Company OxyTOTE Portable Oxygen Unit May Ignite and Burst
Recall Class: Class I Date Recall Initiated: 1/31/2015 Devices: Affected Lot and Model Numbers Manufacturing and Distribution Dates: January 1, 2009 to September 30, 2014 Number of Units Distributed in the U.S.: 161,674 Use: Portable oxygen units provide oxygen to patients to help regulate their breathing while allowing them to travel around. Pressurized oxygen is…
Class II Special Controls Guideline: Nucleic Acid Amplification Assays for the Detection of Trichomonas vaginalis
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Global Unique Device Identification Database (GUDID): Data Submission Compliance Date of September 24, 2015
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Infections Associated with Reprocessed Duodenoscopes (Updated)
Background FDA’s Ongoing Investigation May 2015 Advisory Committee Meeting Additional Resources Background Duodenoscopes are flexible, lighted tubes that are threaded through the mouth, throat, and stomach into the top of the small intestine (duodenum). They are used during endoscopic retrograde cholangiopancreatography (ERCP), a potentially life-saving procedure to diagnose and treat problems in the pancreas and…
Problem with Quality of Mammograms at Boston Diagnostic Imaging in Orlando, Florida: FDA Safety Communication
Date Issued: August 17, 2015 Audience: Patients who had mammograms at Boston Diagnostic Imaging located in Orlando, Florida, any time on or after May 13, 2013. Health care providers who have referred patients to Boston Diagnostic Imaging located in Orlando, Florida, for a mammogram performed any time on or after May 13, 2013. Medical Specialty:…