Categories
rss

Olympus Issues Medical Device Advisory Notice to Use Alternative Devices to the MAJ-891 Forceps/Irrigation Plug

Murilo Freitas - 05:00, 29 de January de 202533
Olympus Corporation has announced a voluntary Advisory Notice for the Forceps/Irrigation Plug (Isolated Type) model MAJ-891 related to the risk of device contamination that may result from improper reprocessing of the MAJ-891 accessory.

http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/olympus-issues-medical-device-advisory-notice-use-alternative-devices-maj-891-forcepsirrigation-plug

 
Categories
rss

Provepharm Inc. Issues Voluntary Nationwide Recall of One Lot of Phenylephrine Hydrochloride Injection, USP, 10 mg/ mL (Pharmacy Bulk Package) Due to Presence of Particulate Matter

Murilo Freitas - 05:00, 23 de January de 202553
Collegeville, Pennsylvania, Provepharm Inc. is voluntarily recalling lot number 24020027; Expiry Date December 2025 of Phenylephrine hydrochloride Injection, USP, 10 mg/ mL (Pharmacy Bulk Package) at the hospital/institutional level. This recall was initiated based on a customer complaint from a pha

http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/provepharm-inc-issues-voluntary-nationwide-recall-one-lot-phenylephrine-hydrochloride-injection-usp

 
Categories
rss

Copaxone, Glatopa (glatiramer acetate): Drug Safety Communication – FDA Adds Boxed Warning About a Rare but Serious Allergic Reaction Called Anaphylaxis

Murilo Freitas - 05:00, 21 de January de 202553
The FDA is warning about the risk of a rare but serious allergic reaction with the medicine glatiramer acetate (Copaxone, Glatopa), which is used to treat patients with multiple sclerosis (MS). This serious allergic reaction, called anaphylaxis, can occur at any time while on treatment, after the fi

http://www.fda.gov/safety/medical-product-safety-information/copaxone-glatopa-glatiramer-acetate-drug-safety-communication-fda-adds-boxed-warning-about-rare

 
Categories
rss

Max Mobility / Permobil Issues Nationwide Recall of SmartDrive Speed Control Dial Due to the Motor Being Unresponsive to the User

Murilo Freitas - 20:00, 16 de January de 202583
Max Mobility/Permobil has initiated a nationwide recall of the Speed Control Dial component used with the SmartDrive MX2+ Power Assist Device due to potential safety and performance concerns.

http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/max-mobility-permobil-issues-nationwide-recall-smartdrive-speed-control-dial-due-motor-being

 
Categories
rss

Neonatal Incubator Correction: GE HealthCare Updates Use Instructions for GE HealthCare Giraffe OmniBed Carestation and Incubator Carestation due to Risk of Patient Formaldehyde Exposure

Murilo Freitas - 05:00, 15 de January de 2025100
Newly manufactured Giraffe Omnibed and Incubator Carestations for neonates may put off higher than expected formaldehyde levels for the first week of use.

http://www.fda.gov/medical-devices/medical-device-recalls/neonatal-incubator-correction-ge-healthcare-updates-use-instructions-ge-healthcare-giraffe-omnibed

 
Categories
rss

FDA Proposes Significant Step Toward Reducing Nicotine to Minimally or Nonaddictive Level in Cigarettes and Certain Other Combusted Tobacco Products

Murilo Freitas - 14:08, 14 de January de 202569

FDA Proposes Significant Step Toward Reducing Nicotine to Minimally or Nonaddictive Level in Cigarettes and Certain Other Combusted Tobacco Products
http://www.fda.gov/news-events/press-announcements/fda-proposes-significant-step-toward-reducing-nicotine-minimally-or-nonaddictive-level-cigarettes

 
PRAIS 2.0