FDA issues highest recall for certain breathing circuits, catheters, spinal cord stimulators
The Food and Drug Administration has identified Class I recalls of the following products: Hudson RCI Neonatal/Infant Heated Wire Breathing Circuits and certain reprocessed electrophysiology and ultrasound catheters by Medline, and all unused Infinion CX Leads by Boston Scientific. The FDA also issued early alerts for other medical products: certain VentStar Resus Neo hoses by Draeger, and certain convenience kits and IV start kits by AVID Medical.
Correction notices were issued for certain Medline convenience kits containing recalled BD ChloraPrep Applicators, as well as Portrait Mobile Monitoring Solutions devices by GE Healthcare. Additionally, voluntary recalls were issued for certain lots of intravenous fluids by American Regent and B. Braun Medical.