Gambro Cartridge Low Weight-Low Volume Blood Transport System for Hemodialysis Blood Set - Product Usage: is intended for single use in a hemodialysis treatment using Dialysis Delivery Systems.

Reason: Potential disconnection of tubing set.

Code information: Product Code: 114435; UDI: 37332414112401; Lot Numbers: 1000212228, 1000215484, 1000224531

Distribution pattern: Worldwide distribution - US Nationwide distribution including in the states of AL, AZ, CA, CO, CT, DC, DE, FL, GA, GU, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY. Countries of Australia, Austria, Bahrain, Belgium, Canada, Denmark, Egypt, Finland, France, Germany, Greece, Israel, Italy, Kuwait, Lithuania, Latvia, Montenegro, Morocco, Netherlands, Norway, Poland, Russia, Serbia, Slovenia, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom, Korea, Singapore, Hong Kong