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Edwards Lifesciences is recalling the Miller Balloon Atrioseptostomy Catheter and Fogarty Dilation Atrioseptostomy Catheter because of the possibility...

Sources:
  • Food and Drug Administration
Relevant To:
  • 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...

Sources:
  • Food and Drug Administration
Relevant To:
  • 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...

Sources:
  • Food and Drug Administration
Relevant To:
  • 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,...

Sources:
  • Food and Drug Administration
Relevant To:
  • 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...

Sources:
  • Centers for Medicare and Medicaid Services
Relevant To:
  • 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...

Sources:
  • Food and Drug Administration
Relevant To:
  • All Healthcare Organizations

Torrent Pharmaceuticals Limited is expanding its recall for Losartan Potassium Tablets USP and Losartan Potassium/hydrochlorothiazide tablets, US...

Sources:
  • Food and Drug Administration
Relevant To:
  • 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...

Sources:
  • Office of Inspector General
Relevant To:
  • Dialysis Facilities,
  • Home Health

The Joint Commission is conducting a field review on proposed standards for perinatal care for their Hospital Accreditation Program. The two prop...

Sources:
  • The Joint Commission
Relevant To:
  • Hospitals

The Joint Commission (TJC) has released a new Quick Safety Issue #48 to address drug diversion and impaired health care workers. According to TJC...

Sources:
  • The Joint Commission
Relevant To:
  • All Healthcare Organizations

Brainlab is recalling the Spine & Trauma 3D Navigation Software due to the potential for incorrect information to display during surgery that...

Sources:
  • Food and Drug Administration
Relevant To:
  • 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...

Sources:
  • Food and Drug Administration
Relevant To:
  • All Healthcare Organizations

The U.S. Food and Drug Administration (FDA) has ordered the manufacturers of all remaining surgical mesh products indicated for the transvaginal ...

Sources:
  • Food and Drug Administration
Relevant To:
  • All Healthcare Organizations

In a letter responding to concerns raised by the National Comprehensive Cancer Network, American Society of Clinical Oncology, American Society o...

Sources:
  • Centers for Disease Control and Prevention
Relevant To:
  • All Healthcare Organizations

The U.S. Food and Drug Administration (FDA) is issuing this communication to update the Safety Communication issued December 2018 regarding resul...

Sources:
  • Food and Drug Administration
Relevant To:
  • Critical Access Hospitals,
  • Hospitals,
  • Ambulatory Care