Recall Z-1861-2008 ยท FJK Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
Gambro Renal Products, Inc.
Gambro Cartridge Blood Set, 0141080XXXC, is intended for single use in a hemodialysis treatment using the Phoenix and Centry system 3 Dialysis Delivery Systems.
| Date | Sep 26, 2008 (initiated May 2, 2008) |
| Status | Terminated |
| Reason | Dialysis tubing sets may have occlusions restricting blood flow. |
| Root cause | Process control |
| Action | Customers were sent an "Urgent Product Safety Notice" letter on 05/02/2008. They were instructed to visually inspect all blood sets prior to connection to the dialyzer to ensure there were no occlusions or partial occlusions. On 05/27/2008, an "Urgent Product Recall" letter was sent to all customers requesting the return of all remaining affected blood sets. |
| Distribution | Nationwide Distribution --- including states of CA,GA, IL, KY, MO, NJ, NM, NY, NC, ND, PA, TN, and VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K070414 | GAMBRO CARTRIDGE BLOOD SETS Gambro Renal Products, Oct 12, 2007 |