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August 7, 2019 UPDATE: Treatment of Peripheral Arterial Disease with Paclitaxel-Coated Balloons and Paclitaxel-Eluting Stents Potentially Associated with Increased Mortality

FDA MedWatch -

The FDA is providing updated information about a late mortality signal in patients treated for peripheral artery disease (PAD) in the femoropopliteal artery with paclitaxel-coated balloons and paclitaxel-eluting stents. This communication updates the January 17 and March 15, 2019 notifications.

Sandoz, Inc. Issues Nationwide Recall of One Lot of Enoxaparin Sodium Injection, USP 40mg/0.4 mL Due to Temperature Excursion During Shipping

FDA MedWatch -

Princeton, NJ, Sandoz Inc. (“Sandoz”) is initiating a recall of one lot (SAB06761A, Exp 04/2023) of Enoxaparin Sodium Injection, USP 40 mg/0.4 mL Single-Dose Syringes to the consumer level. A portion of lot SAB06761A experienced a temperature excursion during shipment. Enoxaparin Sodium for Injectio

Teleflex Incorporated Announces Worldwide Recall of Arrow-Trerotola™ Over-The-Wire PTD® Kit Percutaneous Thrombolytic Device: 7FR

FDA MedWatch -

Teleflex Incorporated (NYSE: TFX), a leading global provider of medical technologies for critical care and surgery, has announced a worldwide recall of Arrow-Trerotola™ Over-The-Wire PTD® Kit Percutaneous Thrombolytic Device: 7FR. The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter,

ABIM Foundation and the Institute for Healthcare Improvement Partner to Build Trust in US Health Systems

Institute for Healthcare Improvement -

Trust at all levels of the health care system is at historic lows, affecting quality of care and equity among patients and communities. That’s why the ABIM Foundation and the Institute for Healthcare Improvement (IHI) are partnering to identify and promote practices, policies, and behaviors for rebuilding trust in US health care systems.

American Screening LLC issues a Voluntary Nationwide Recall of American Screening Hand Sanitizer Packaged in 8 oz Bottles Because They Resemble Beverage Containers

FDA MedWatch -

American Screening LLC of Shreveport, Louisiana is voluntarily recalling 153,336 units of Hand Sanitizer, containing 70% ethyl alcohol gel to the consumer level. The hand sanitizer is packaged in 8 oz. containers that resemble water bottles posing a risk of consumption. Ingesting hand sanitizer, whi

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