Health care providers should stop using certain syringes and needles with needle safety devices made by Guangdong Haiou Medical Apparatus Co. until further notice due to quality issues, including certain needles detaching from the syringe after injection and other needle safety device failures, the Food and Drug Administration said today in a letter to health care providers. The letter includes details on the syringe and needle configurations; recommendations for health care facility risk managers; and instructions for reporting problems with the devices. 
 
In other news, the FDA today released a discussion paper seeking input from stakeholders through July 19 on how to include specific materials information in medical device labeling to help patients and health care providers make informed decisions regarding medical device use. 
 

Related News Articles

Headline
The Food and Drug Administration today approved the first interchangeable biosimilar product for Humira, a monoclonal antibody used to treat certain…
Headline
Abbott Molecular Inc. yesterday issued a recall for its Alinity m SARS-CoV-2 AMP Kits and Alinity m Resp-4-Plex AMP Kits, distributed between May 13, 2020, and…
Headline
The Food and Drug Administration and Magellan Diagnostics Inc. today expanded the ongoing recall of LeadCare II, LeadCare Plus and LeadCare Ultra Blood Lead…
Headline
The Food and Drug Administration today announced it will withdraw regulations for non-drug manufacturers who produced during the COVID-19 public health…
Headline
DeRoyal Industries recently recalled more than 2,800 procedure packs distributed in the U.S. that could expose patients to harmful levels of aluminum. The…
Headline
The Food and Drug Administration yesterday authorized the emergency use of a new over-the-counter COVID-19 antigen test. Unlike most antigen tests for at-…