Class I Recall For Medline’s Saline Solution Packs
Executive Summary
Medline Industries has issued a recall of some of its saline solution products for being non-sterile. The US FDA has designated the recall class I.
You may also be interested in...
Teleflex Continues Restructuring By Selling Hudson Respiratory Business To Medline
Medline will pay $286m in cash for Teleflex's oxygen and aerosol therapy, active humidification, and non-invasive ventilation devices as well as incentive spirometers. Those businesses yielded $139m in 2020 revenues, but do not fit into Teleflex's plan for the future.
eSTAR Now Open For PMA Submissions
The US FDA electronic submission process for streamlining its product review process is now available for sponsors submitting some premarket approval applications.
FDA Evaluating Safety Of Plastic Syringes From China, May Prevent Their Import To The US
The US FDA is advising the public that certain plastic syringes from China could fail, leak, or break. If necessary, the agency may prevent Chinese syringes from entering the US.