Gambro Cartridge Low Volume 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 Gambro Cartridge Low Volume Blood Transport System for Hemodialysis Blood Set products due to a potential disconnection of the tubing set during use. The affected products are intended for single use in hemodialysis treatment and were distributed worldwide, including throughout the United States and in multiple countries including Canada, Australia, and various European nations. A total of 19,800 units with product code 114434 and specific lot numbers (1000201510, 1000206870, 1000214235, 1000218202, and 1000224530) are involved in this recall.
The source document does not specify a remedy or recommended action for consumers who have this product.
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: 19,800 units Lot/code info: Product Code: 114434; UDI: 47332414112395; Lot Numbers: 1000201510, 1000206870, 1000214235, 1000218202, 1000224530
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.