FDA

Latest Issue of OR Manager
October 2017

FDA clears first duodenoscope with disposable end cap

Editor's Note The Food and Drug Administration (FDA) on September 20 cleared the first duodenoscope with a disposable end cap, which will improve access for cleaning and reprocessing. The new features of the Pentax ED34-i10T duodenoscope include a single-use detachable and disposable distal cap, simpler user interface, improved ergonomics, improved…

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By: Judy Mathias
September 21, 2017
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FDA updates Safety Alert for urogynecologic surgical mesh by Boston Scientific

Editor's Note The Food and Drug Administration (FDA) on September 19 updated its Safety Alert for urogynecologic surgical mesh manufactured by Boston Scientific. After an extensive review of data and testing, the FDA has determined that the change in supplier of the polypropylene used to manufacture the mesh currently on…

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By: Judy Mathias
September 19, 2017
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FDA: OriGen recalls two lots of dual lumen ECMO catheters

Editor's Note The Food and Drug Administration (FDA) on September 13 announced the recall by OriGen Biomedical (Austin, Texas) of two lots of its VV28F Reinforced Dual Lumen ECMO [extracorporeal membrane oxygenation] Catheters (Catalog number VV28F, Lots N18487 and V18487-1). The recall was initiated because the catheters have the potential…

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By: Judy Mathias
September 14, 2017
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FDA to staff new digital health unit

Editor's Note The Food and Drug Administration (FDA) is filling 13 positions in a new digital health unit that was created as part of the FDA Reauthorization Act of 2017, the September 11 FierceHealthcare reports. The FDA intends to build a group of experts who are experienced with software lifecycle…

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By: Judy Mathias
September 13, 2017
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FDA: Class I recall of Datascope/MAQUET intra-aortic balloon pumps

Editor's Note The Food and Drug Administration (FDA) on September 6 categorized the recall by Datascope/MAQUET of its CS100i, CS100, and CS300 intra-aortic balloon pumps as Class I, the most serious. The recall was initiated because of a false blood detection alarm and ingress of fluid into the balloon pump.…

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By: Judy Mathias
September 11, 2017
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FDA: Genetech recalls three lots of Activase

Editor's Note The Food and Drug Administration (FDA) on September 7 announced the recall by Genetech (South San Francisco, California) of three lots of Activase (alteplase) 100 mg vials that were co-packaged with sterile water for injection. The vials of water, manufactured by Hospira Inc (Lake Forest, Illinois), may be…

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By: Judy Mathias
September 11, 2017
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FDA: Recall of Hydromorphone HCL and Levophed Injection by Hospira

Editor's Note The Food and Drug Administration (FDA) on September 5 announced the recall by Hospira Inc (Lake Forest, Illinois) of one lot of Hydromorphone HCL injection, USP, CII 2 mg/mL and four lots of Levophed (norepinephrine bitartrate) injection because of a lack of sterility assurance resulting from a damaged…

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By: Judy Mathias
September 6, 2017
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FDA issues alert for alcohol pads, benzalkonium chloride antiseptic towelettes by Foshan Flying Medical Products

Editor's Note The Food and Drug Administration (FDA) on September 1 issued a Safety Alert notifying healthcare professionals and patients not to use alcohol pads or benzalkonium chloride antiseptic towelettes made by Foshan Flying Medical Products Co Ltd (China) because of lack of sterility and other quality issues. Use of…

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By: Judy Mathias
September 6, 2017
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FDA: Hospira recalls one lot of vancomycin hydrochloride

Editor's Note The Food and Drug Administration (FDA) on August 31 announced the recall by Hospira Inc (Lake Forest, Illinois) of one lot of vancomycin hydrochloride for injection, USP, 750 mg/vial (NDC 0409-6531-02) lot 632153A. The recall was initiated because of a customer report of the presence of particulate matter,…

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By: Judy Mathias
September 5, 2017
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FDA recommends use of thermal regulating systems during surgery

Editor's Note The Food and Drug Administration (FDA) on August 30 issued a Safety Alert reminding healthcare providers that using thermal regulating systems, including forced air systems, during surgical procedures has been shown to result in less bleeding, faster recovery times, and decreased risk of infections for patients. The FDA…

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By: Judy Mathias
September 1, 2017
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Hot Products
Product Spotlight: 3M Clean-Trace ATP Cleaning Monitoring System

The 3M™ Clean-Trace™ ATP Cleaning Monitoring System provides real-time cleaning efficacy data to clearly indicate whether an endoscope or other surgical instrument has been adequately

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