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Ultimate Body Tox PRO: Recall
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Transcripts posted for November 9-10, 2016 Microbiology Devices Panel of the Medical Devices Advisory Committee
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Class I Medical Device Recall: Medtronic Recalls Neurovascular Products due to Potential Separation and Detachment of Polytetrafluoroethylene (PTFE) Coating
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Products: Pipeline Embolization Device, Alligator Retrieval Device, Marathon Flow Directed Micro Catheter, and X-Celerator Hydrophilic Exchange Guidewire Lot Numbers: See full list of lot numbers Distribution Dates: November…
Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN140040 added)
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Presentation and Transcript added to Webinar – Final Guidance Documents: Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use and Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use
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Mitigating the Risk of Cross-Contamination from Valves and Accessories Used for Irrigation Through Flexible Gastrointestinal Endoscopes
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DMAA Net Weight 500g by NutriVitaShop: Recall
[Posted 11/26/2016] AUDIENCE: Consumer ISSUE: NutriVitaShop, also doing business as Naturecom Inc. Lake Forest, CA is requesting the nationwide recall of its DMAA net weight 500g because there may be presence of DMAA. Lot numbers include #20141102, 20150715, 20151022, 20160226, 20160701, 20161017 and 20150323. DMAA net weight 500g is packaged in approximately 8″ x 11”…
Products Containing Belladonna Extract by Raritan Pharmaceuticals: Recall
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FindrWIRZ Guidewire System by SentreHeart: Class I Recall
[Posted 11/22/2016] AUDIENCE: Surgery, Cardiology, Neurology, Risk Manager ISSUE: SentreHeart is recalling the FindrWIRZ Guidewire System because the PTFE coating may separate (e.g., peel, flake, shed, delaminate, slough off) from the packaging and potentially cause serious injuries to patients. Coating separation may be caused by issues with the device design or manufacturing processes. Lot Numbers…