Baxter recalls two lots of 0.9% sodium chloride injection
Editor's Note Baxter International Inc has announced a recall of two lots of 0.9% sodium chloride injection, USP, 50 mL and 100 mL, because of the presence of particulate matter. The lot numbers are P319921 and P327635. The particulate matter was determined to be an insect and was identified as…
FDA: Class I recall of Medtronic’s Covidien Shiley pediatric trach tubes
Editor's Note The Food and Drug Administration on June 15 issued a Class I recall, the most serious, of certain Covidien Shiley neonatal and pediatric tracheostomy tubes by Medtronic. The recalled tubes were formed with a wider-angle bend than standard models. The company has received reports that patients switching tubes…
FDA issues draft guidance on requirements for surgical gowns
Editor's Note The Food and Drug Administration has issued a draft guidance to describe its premarket regulatory requirements and performance testing needed to support liquid barrier claims for gowns used in health care settings. In the past, a number of terms have been used to refer to gowns intended for…
FDA: Class I recall of Maquet FLOW-I Anesthesia Systems
Editor's Note The Food and Drug Administration on July 1 issued a Class I recall, the most serious, of FLOW-I Anesthesia Systems by Maquet. Maquet has received 10 reports of patient cassettes (ie, the center of gas flow in the system) coming loose. The cassette locking device may accidentally release…
First step taken in FDA-issued unique device identification system
Medical device manufacturers have taken the first step in complying with the 7-year unique device identification (UDI) process mandated by the Food and Drug Administration (FDA). The UDI system establishes a consistent way to label and track medical devices from production to use, and is intended to improve patient safety…
FDA, Joint Commission cite safety concerns with power morcellation
Reports about problems associated with power morcellation in gynecologic surgery led to safety warnings in November 2014 by the Food and Drug Administration (FDA) and the Joint Commission. The FDA on November 24 updated its Safety Communication on the use of laparoscopic power morcellation in hysterectomies and myomectomies. The previous…
FDA issues Unique Device Identification final rule
The Food and Drug Administration (FDA) on September 24 published the final rule for its Unique Device Identification (UDI) system to provide a consistent way to identify medical devices throughout their distribution and use. “A UDI system for medical devices is an important step towards increasing patient safety, modernizing postmarket…
ORs could see benefits from FDA's UDI system
Your OR could see real benefits from the Food and Drug Administration’s (FDA) proposed unique device identification (UDI) system. But will your systems be ready to capture, record, and retrieve UDI information? Comments on the FDA’s UDI proposed rule are due by November 7, 2012. The proposal was published July…
FDA proposes a UDI system for medical devices
The US Food and Drug Administration (FDA) released its long awaited proposed rule for a unique device identification (UDI) system on July 3, 2012. Comments will be accepted for 120 days after the proposed rule is published in the Federal Register, which was expected in early July. The rule would…
FDA issues notice regarding the Steris System 1 processor
The Food and Drug Administration (FDA) in a December 3, 2009 notice outlined regulatory concerns about the Steris System 1 processor and recommended that facilities make a transition to alternative products as soon as possible. In the notice, the FDA says Steris has "significantly modified" the Steris System 1 over…
Free Daily News
- Medical device coating could reduce blood clot risks
- FDA pilot program aims to expedite high-risk medical device recall communication
- Surgeons implant first medically suspended heart pump in US
- Study: COVID-19's impact on oncological surgery offers lessons for future crises
- Study links pandemic stress to persistent increases in nursing-sensitive quality indicators
- Save the date for the 2025 OR Business Management Conference
- Study: Education, exercise improve knee OA with or without prior surgery
- Study: Early surgery outperforms endoscopy for long-term pancreatitis
- Study: Blood thinner, NSAID combination raises bleeding risk
- Hospital financial report predicts stability, high cybersecurity costs for 2025