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Class I Recall of Edwards Lifesciences Recalls Miller and Fogarty Atrioseptostomy Dilation Catheters
04/26/2019Edwards Lifesciences is recalling the Miller Balloon Atrioseptostomy Catheter and Fogarty Dilation Atrioseptostomy Catheter because of the possibility...
- Food and Drug Administration
- All Healthcare Organizations
The US Food and Drug Administration (FDA) has issued a safety communication to provide the results from the mandated postmarket surveillance stud...
- Food and Drug Administration
- Critical Access Hospitals,
- Hospitals
Legacy Pharmaceutical Packaging, LLC is expanding its consumer-level recall of 3 repackaged lots Losartan Tablets USP 50mg to include one additio...
- Food and Drug Administration
- All Healthcare Organizations
The US Food and Drug Administration has granted final approval of the first generic naloxone hydrochloride nasal spray, commonly known as Narcan,...
- Food and Drug Administration
- All Healthcare Organizations
The US Centers for Medicare and Medicaid Services (CMS) has released a draft policy memorandum intended to clarify interpretive guidance on ligat...
- Centers for Medicare and Medicaid Services
- Hospitals,
- Behavioral Health
Alvogen, Inc. is voluntarily recalling two lots of Fentanyl Transdermal System 12 mcg/h transdermal patches to the consumer level. A small number...
- Food and Drug Administration
- All Healthcare Organizations
Torrent Pharmaceuticals Limited is expanding its recall for Losartan Potassium Tablets USP and Losartan Potassium/hydrochlorothiazide tablets, US...
- Food and Drug Administration
- All Healthcare Organizations
The Office of the Inspector General (OIG) recently released updates to their Work Plan. In 2017, OIG transition from a yearly to a monthly Work P...
- Office of Inspector General
- Dialysis Facilities,
- Home Health
Joint Commission Proposed Standards for Perinatal Safety in the Hospital Accreditation Program
04/18/2019The Joint Commission is conducting a field review on proposed standards for perinatal care for their Hospital Accreditation Program. The two prop...
- The Joint Commission
- Hospitals
New Joint Commission Quick Safety Issue Addresses Drug Diversion and Impaired Health Care Workers
04/17/2019The Joint Commission (TJC) has released a new Quick Safety Issue #48 to address drug diversion and impaired health care workers. According to TJC...
- The Joint Commission
- All Healthcare Organizations
Brainlab is recalling the Spine & Trauma 3D Navigation Software due to the potential for incorrect information to display during surgery that...
- Food and Drug Administration
- All Healthcare Organizations
The U.S. Food and Drug Administration (FDA) is alerting health care professionals, parents and caregivers that there is a temporary shortage of a...
- Food and Drug Administration
- All Healthcare Organizations
FDA Orders Manufacturers of Surgical Mesh for Transvaginal Repair to Stop Selling Product
04/16/2019The U.S. Food and Drug Administration (FDA) has ordered the manufacturers of all remaining surgical mesh products indicated for the transvaginal ...
- Food and Drug Administration
- All Healthcare Organizations
CDC Letter Clarifies Opioid Guidance
04/15/2019In a letter responding to concerns raised by the National Comprehensive Cancer Network, American Society of Clinical Oncology, American Society o...
- Centers for Disease Control and Prevention
- All Healthcare Organizations
FDA Safety Communication Addresses Importance of Following Duodenoscope Reprocessing Instructions
04/12/2019The U.S. Food and Drug Administration (FDA) is issuing this communication to update the Safety Communication issued December 2018 regarding resul...
- Food and Drug Administration
- Critical Access Hospitals,
- Hospitals,
- Ambulatory Care