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Arrow International Intra-Aortic Balloon Catheter Kits and Percutaneous Insertion Kits by Teleflex Incorporated : Class I Recall
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Amikacin Sulfate Injection USP, 1 gram/4mL (250 mg/mL) Vials by Teva: Recall
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Human and Animal Sterile Drug Products by I.V. Specialty: FDA Alert
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Fluconazole Injection, USP, (in 0.9 Percent Sodium Chloride) 200mg per 100ml: Recall
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MitraClip Delivery System by Abbott: Safety Notice
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Neurosurgical Head Holders (Skull Clamps) : FDA Safety Communication
[Posted 02/25/2016] AUDIENCE: Surgery, Neurology, Orthopedics, Otolaryngology ISSUE: From January 2009 to January 2016, the FDA received more than 1,000 medical device reports (MDRs) associated with the slippage or movement of a skull clamp before and/or during surgical procedures, resulting in more than 700 injuries. These reports describe unintended patient movement during surgical procedures that…
ED-3490TK Video Duodenoscope by Pentax: FDA Safety Communication
[Posted 02/19/2016] AUDIENCE: Risk Manager, Gastroenterology, Surgery, Infectious Disease, Nursing ISSUE: PENTAX has issued updated, validated manual reprocessing instructions for the ED-3490TK Video Duodenoscope to replace those provided in the original device labeling. The FDA reviewed these updated reprocessing instructions and the validation data and recommends that facilities using PENTAX ED-3490TK Video Duodenoscopes train staff…
0.9 Percent Sodium Chloride Solution for Irrigation by Baxter: Recall
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Morphine Sulfate 0.5 mg/mL Preservative Free in 0.9 percent Sodium Chloride by Pharmakon Pharmaceuticals: Recall – Super
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