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Recalled masks have magnets that can cause injuries or death when the mask is near certain implanted metallic medical devices or metallic objects in the body.
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FDA Roundup: January 16, 2024
FDA Roundup: January 16, 2024
http://www.fda.gov/news-events/press-announcements/fda-roundup-january-16-2024
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FDA Roundup: January 12, 2024
FDA Roundup: January 12, 2024
http://www.fda.gov/news-events/press-announcements/fda-roundup-january-12-2024
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Fresenius Kabi USA, LLC Recalls Ivenix Large Volume Pump (LVP) of the Ivenix Infusion System Due to Mechanical Interference
Fresenius Kabi is recalling the Ivenix Large Volume Pump (LVP) for mechanical issues causing the internal Fluid Valve Pins not to move correctly.
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Certain Type of Medicines Approved for Type 2 Diabetes and Obesity: Drug Safety Communication – Update on FDA’s Ongoing Evaluation of Reports of Suicidal Thoughts or Actions
The FDA has been evaluating reports of suicidal thoughts or actions in patients treated with a class of medicines called glucagon-like peptide-1 receptor agonists. FDA’s preliminary evaluation has not found evidence that use of these medicines causes suicidal thoughts or actions.
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Busse Hospital Disposables, Inc. Recalls Care Trays and Kits Containing Sterile Water Based Products Under Recall by Nurse Assist
Busse Hospital Disposables is recalling their Tracheostomy Care Trays and sets in response to Nurse Assist’s November saline recall due to sterility concerns.
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FDA Roundup: January 9, 2024
FDA Roundup: January 9, 2024
http://www.fda.gov/news-events/press-announcements/fda-roundup-january-9-2024
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FDA Facilitates Broader Adoption of Vaporized Hydrogen Peroxide for Medical Device Sterilization
FDA Facilitates Broader Adoption of Vaporized Hydrogen Peroxide for Medical Device Sterilization
http://www.fda.gov/news-events/press-announcements/fda-facilitates-broader-adoption-vaporized-hydrogen-peroxide-medical-device-sterilization
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Insulet Corporation Recalls Omnipod 5 Android App due to a Software Error
Omnipod 5 App recalled due to a software error which occurs when users input bolus amounts below 1 unit without adding a zero before the decimal point.
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Leiters Health Issues Voluntary Nationwide Recall of Vancomycin IV Bags, Phenylephrine IV Bags, and Fentanyl IV Bags Due to Potential for Superpotent Drug
January 5, 2024 – Englewood, Colorado, Leiters Health is voluntarily recalling 33 lots of products listed below to the user level. The recalled batches of vancomycin IV bags, phenylephrine IV bags, and fentanyl IV bags are being recalled due to the potential for superpotency because they may contain