U.S. Food and Drug Administration (FDA) has issued a class I recall concerning Custom Dialysis Trays/Kits manufactured by Lee Medical International Inc.
The custom dialysis kits are designed to include all the components (gloves, bandages, fistula needles, antibacterial pads [Povidone Iodine (PVP) Prep Pads], and specific bloodlines) used in preparing hemodialysis vascular access sites for patients undergoing dialysis procedures. The PVP Prep Pads were recalled by H & P Industries because the pads may not be sterile. Patients receiving hemodialysis who use the pads may be at potential risk for serious or life threatening infection.
For details, please visit the following FDA website: http://www.fda.gov/MedicalDevices/Safety/ucm272167.htm
If you are in possession of the affected product, please contact your supplier for necessary actions.