Categories
rss

UPDATE: Do Not Use Cue Health’s COVID-19 Tests Due to Risk of False Results: FDA Safety Communication

Murilo Freitas - 04:00, 15 de October de 2024243
The FDA issues alert about risk of false results with Cue Health’s COVID-19 Tests due to modifications made without FDA authorization that have a strong likelihood to impact performance.

http://www.fda.gov/medical-devices/safety-communications/update-do-not-use-cue-healths-covid-19-tests-due-risk-false-results-fda-safety-communication

 
Categories
rss

Staska Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Ascorbic Acid Solution for Injection (Preservative Free, Non-Corn) 500mg/mL Due to the Presence of Glass Particles

Murilo Freitas - 04:00, 15 de October de 2024224
Bennet, NE, STASKA PHARMACEUTICALS, INC. is voluntarily recalling 1 lot of Ascorbic Acid Solution for Injection (Preservative Free, Non-Corn) 500mg/mL, 50mL vials to the user level. This is due to the presence of glass particulates in one lot of vials used in the production of this batch.

http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/staska-pharmaceuticals-inc-issues-voluntary-nationwide-recall-ascorbic-acid-solution-injection

 
Categories
rss

C&A Naturistics Issues Voluntary Nationwide Recall of AK Forte Tablets con Ortiga y Omega 3 Due to the Presence of Undeclared Drug Ingredients: Diclofenac, Dexamethasone, and Methocarbamol

Murilo Freitas - 04:00, 15 de October de 2024506
10/8/24 – National City, CA, C&A Naturistics is voluntarily recalling all lots of AK Forte, 400 mg tablets, to the consumer level. FDA analysis has found the product to be tainted Diclofenac, Dexamethasone, and Methocarbamol. Products containing diclofenac, dexamethasone, and methocarbamol cannot b

http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/ca-naturistics-issues-voluntary-nationwide-recall-ak-forte-tablets-con-ortiga-y-omega-3-due-presence

 
Categories
rss

Infusion Pump Recall: Zyno Medical Removes Z-800, Z-800F, Z-800W, and Z800WF Infusion Pumps due to an Air-in-Line Software Defect That May Allow Larger than Expected Air Bubbles to Enter Patients

Murilo Freitas - 04:00, 14 de October de 2024356
Zyno Medical Z-800 infusion pumps allow for infusions through the blood vessels but a software defect may allow air bubbles to enter the patient.

http://www.fda.gov/medical-devices/medical-device-recalls/infusion-pump-recall-zyno-medical-removes-z-800-z-800f-z-800w-and-z800wf-infusion-pumps-due-air-line

 
Categories
rss

Federal Court Enters Consent Decree Against Rizo Lopez Foods Inc. Following Multistate Outbreak of Listeriosis Linked to Queso Fresco and Cotija Cheese Products

Murilo Freitas - 20:40, 7 de October de 2024311

Federal Court Enters Consent Decree Against Rizo Lopez Foods Inc. Following Multistate Outbreak of Listeriosis Linked to Queso Fresco and Cotija Cheese Products
http://www.fda.gov/news-events/press-announcements/federal-court-enters-consent-decree-against-rizo-lopez-foods-inc-following-multistate-outbreak

 
Categories
rss

Resuscitator Recall: Mercury Medical Removes Neo-Tee T-Piece Resuscitators due to Risk of Inline Controller Detachment that May Impact Ventilation

Murilo Freitas - 04:00, 6 de October de 2024315
Neo-Tee Resuscitators are used for emergency breathing support for neonates and infants. The inline controller may come apart and impact ventilation.

http://www.fda.gov/medical-devices/medical-device-recalls/resuscitator-recall-mercury-medical-removes-neo-tee-t-piece-resuscitators-due-risk-inline-controller

 
PRAIS 2.0