Gambro Cartridge Blood Transport System for Hemodialysis Blood Set - Product Usage: is intended for single use in a hemodialysis treatment using Dialysis Delivery Systems.
Check against the official notice below — it lists the full affected range.
Baxter Healthcare Corporation is recalling the Gambro Cartridge Blood Transport System for Hemodialysis Blood Set due to a potential disconnection of the tubing set during hemodialysis treatment. The product is intended for single use with Dialysis Delivery Systems. Approximately 53,895 units have been distributed worldwide and throughout the United States, as well as to Australia, Austria, Bahrain, Belgium, Canada, Denmark, Egypt, Finland, France, Germany, Greece, Israel, Italy, Kuwait, Lithuania, and Latvia.
The affected product has Product Code 109536 and UDI 37332414085217, with the following lot numbers: 1000205902, 1000214627, 1000222392, and 1000226807. The source document does not specify a remedy or recommended course of action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
Potential disconnection of tubing set.
Reason for recall: Potential disconnection of tubing set. Distribution: 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 Quantity: 53,895 units Lot/code info: Product Code: 109536; UDI: 37332414085217; Lot Numbers: 1000205902, 1000214627, 1000222392, 1000226807
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.