Recall Z-2194-2020 ยท FJK Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
Baxter Healthcare Corporation
Gambro Cartridge Blood Transport System for Hemodialysis Blood Set - Product Usage: is intended for single use in a hemodialysis treatment using Dialysis Delivery Systems.
| Date | Apr 17, 2020 |
| Status | Terminated |
| Reason | Potential disconnection of tubing set. |
| Root cause | Process control |
| Action | Baxter Healthcare notified customers on about 04/17/2020 via "Urgent Device Correction" letter. Customers were instructed to do the following: 1. Prior to use, thoroughly inspect each connection of the set to check for any detachments in the tubing. Operators may continue to use affected sets if no detachments are observed. Additionally, per the Instructions For Use (IFU), users should observe carefully for leaks during priming and use, and examine the tubing carefully to be certain that all connections are secure, all lines are unobstructed and that there are no kinks or leaks in the tubi |
| Quantity | 53,895 units |
| 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, Bel |
| FDA record | Open on fda.gov |