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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
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FDA Roundup: January 5, 2024
FDA Roundup: January 5, 2024
http://www.fda.gov/news-events/press-announcements/fda-roundup-january-5-2024
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FDA Authorizes Florida’s Drug Importation Program
FDA Authorizes Florida’s Drug Importation Program
http://www.fda.gov/news-events/press-announcements/fda-authorizes-floridas-drug-importation-program
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Getinge / Atrium Medical Corporation Issues Medical Device Correction for Nurse Assist Syringes Provided with Express Drains
On December 13, 2023, Getinge / Atrium Medical Corporation notified affected customers of a nationwide recall (medical device correction) for certain Atrium Express Dry Suction Dry Seal Chest Drains in response to a voluntary medical device recall initiated by a supplier, Nurse Assist. On November
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Do Not Use Synovo Total Hip Resurfacing System: FDA Safety Communication
This device has significantly changed since FDA authorization, and the safety and effectiveness of the modified device has not been established.
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FDA Roundup: January 2, 2024
FDA Roundup: January 2, 2024
http://www.fda.gov/news-events/press-announcements/fda-roundup-january-2-2024
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2023 Letters to Health Care Providers
The FDA posts letters to health care providers about the safe use of medical devices.
http://www.fda.gov/medical-devices/letters-health-care-providers/2023-letters-health-care-providers
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HSV-2 Tests for Genital Herpes Can Produce False Reactive Results – Letter to Clinical Laboratory Staff and Health Care Providers
Herpes simplex virus-2 serological tests can produce false reactive results especially if a person has a low risk of infection or if test results are near the test’s cut-off.
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Hospira, Inc. Issues A Voluntary Nationwide Recall For 4.2% Sodium Bicarbonate Injection, 8.4% Sodium Bicarbonate Injection, and Atropine Sulfate Injection Due to the Potential Presence of Glass Particulate Matter
Hospira, Inc., a Pfizer company, is voluntarily recalling the lots listed in the table below of 4.2% Sodium Bicarbonate Injection, USP ABBOJECT® Glass Syringe, 5 mEq/10 mL; 8.4% Sodium Bicarbonate Injection, USP Lifeshield® ABBOJECT® Glass Syringe, 50 mEq/50 mL; and Atropine Sulfate Injection, USP L
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FDA Roundup: December 22, 2023
FDA Roundup: December 22, 2023
http://www.fda.gov/news-events/press-announcements/fda-roundup-december-22-2023