The FDA has classified a recall of Medline Kits containing Tego Connectors as Class II due to issues with the silicone seal, including doming and tearing. These defects can result in an occluded fluid path, preventing users from injecting or withdrawing fluids, which poses a risk to patient care. The affected products are Medline IR Pack (SKU DYNJ67205C) and Medline NO CATHETER DIALYSIS INSERTION (SKU CVI5200).

Healthcare providers and medical device manufacturers should immediately review their inventory for the affected lots and follow Medline's recall procedures. Failure to properly manage recalled devices can lead to patient harm and regulatory scrutiny. While this is a recall notice, entities should ensure their internal processes for handling such events are robust and compliant with FDA regulations.