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FDA Medwatch News Feed

Medtronic Inc. Recalls HawkOne Directional Atherectomy System Due to Risk of Tip Damage During Use | Fri, 21 Jan 2022 00:00:00 EST

This device is used during an atherectomy to treat patients who have calcified narrowings and blockages in the peripheral arteries.

UPDATE: Blood Specimen Collection Tube Conservation Strategies - Letter to Health Care and Laboratory Personnel | Wed, 19 Jan 2022 00:00:00 EST

The FDA recommends conservation strategies to minimize the use of these tubes and maintain the quality and safety of care for patients.

Mylan Pharmaceuticals Inc., a Viatris Company, Conducting Voluntary Recall of One Batch of Semglee® (insulin glargine injection), 100 units/mL (U-100), 3 mL Prefilled Pens, Due to the Potential for a Missing Label in the Batch | Wed, 19 Jan 2022 00:00:00 EST

Mylan Pharmaceuticals Inc., a Viatris company, is voluntarily recalling one batch of its non-interchangeable Semglee® (insulin glargine injection), 100 units/ml (U-100), 3mL prefilled pens, which are packaged in a labelled carton of five (5) pens. The product is being recalled due to the potential f ...

Getinge USA Sales, LLC Recalls the Vaporizer Sevoflurane Maquet Filling for Flow Family Anesthesia Systems Due to a Risk of Harmful Chemical Exposure | Wed, 19 Jan 2022 00:00:00 EST

Getinge USA Sales, LLC recalls its Vaporizer Sevoflurane Maquet Filling for Flow Family Anesthesia Systems due to a risk of harmful chemical exposure.

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