PRAIS 2.0 – Page 58 – Regional Platform on Access and Innovation for Health Technologies

Outset Medical, Inc. Recalls Certain Tablo Hemodialysis Systems for Risk of Patient Exposure to Higher Than Allowable Levels of Toxic Compound NDL-PCBAs

Murilo Freitas - 04:00, 24 de April de 2024311

The Tablo Hemodialysis System may expose patients to higher than allowable levels of NDL-PCBAs.

http://www.fda.gov/medical-devices/medical-device-recalls/outset-medical-inc-recalls-certain-tablo-hemodialysis-systems-risk-patient-exposure-higher-allowable

rss

InfuTronix, LLC Recalls Nimbus and Nimbus II Infusion Pump Systems for Multiple Device Failures That May Cause Severe Injury and Death

Murilo Freitas - 04:00, 24 de April de 2024269

Nimbus and Nimbus II infusion pumps may experience one or more issues that can cause severe patient injury and death.

http://www.fda.gov/medical-devices/medical-device-recalls/infutronix-llc-recalls-nimbus-and-nimbus-ii-infusion-pump-systems-multiple-device-failures-may-cause

rss

FDA Approves New Treatment for Uncomplicated Urinary Tract Infections

Murilo Freitas - 17:32, 23 de April de 2024270

FDA Approves New Treatment for Uncomplicated Urinary Tract Infections
http://www.fda.gov/news-events/press-announcements/fda-approves-new-treatment-uncomplicated-urinary-tract-infections

rss

DeRoyal Industries, Inc. Recalls Tracecarts Containing 16FR Urine Meter Foley Under Recall by Nurse Assist

Murilo Freitas - 04:00, 23 de April de 2024305

DeRoyal is recalling Surgical Tracecarts with Nurse Assist 16FR Silver Urine Meter Foley due to sterility concerns. Other items in the tracecart are unaffected.

http://www.fda.gov/medical-devices/medical-device-recalls/deroyal-industries-inc-recalls-tracecarts-containing-16fr-urine-meter-foley-under-recall-nurse

rss

FDA Roundup: April 23, 2024

Murilo Freitas - 19:20, 22 de April de 2024325

FDA Roundup: April 23, 2024
http://www.fda.gov/news-events/press-announcements/fda-roundup-april-23-2024

rss

STOP CLOPEZ CORP Issues Voluntary Worldwide Recall of Schwinnng Capsules Due to the Presence of Undeclared Nortadalafil

Murilo Freitas - 04:00, 22 de April de 2024423

Hollywood, FL, US, STOP CLOPEZ CORP is voluntarily recalling one lot of Schwinnng capsules to the consumer level. FDA analysis has found the Schwinnng products to contain Nortadalafil. Nortadalafil is an active drug ingredient known for the treatment of male erectile dysfunction. The presence of Nor

http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/stop-clopez-corp-issues-voluntary-worldwide-recall-schwinnng-capsules-due-presence-undeclared

rss

Dr. Reddy’s Issues Voluntary Nationwide Recall of Sapropterin Dihydrochloride Powder for Oral Solution 100 mg Due to Sub-Potency

Murilo Freitas - 04:00, 22 de April de 2024198

Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY, along with its subsidiaries together referred to as “Dr. Reddy’s”), today announced that it is voluntarily recalling six (6) lots of Sapropterin Dihydrochloride Powder for Oral Solution 100 mg to the consumer leve

http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/dr-reddys-issues-voluntary-nationwide-recall-sapropterin-dihydrochloride-powder-oral-solution-100-mg

RSS OPAS