FDA Recall
Terminated
Gambro Cartridge Blood Set, 003410-510, is intended for single use in a hemodialysis treatment using the Phoenix and Centry system 3 Dialysis Delivery Systems.
Recall: Z-1860-2008
·
Initiated May 2, 2008
Recall
- Recall Number
- Z-1860-2008
- Event Number
- 48148
- Firm
- Gambro Renal Products, Inc.
- FEI Number
- 1713683
- Product Code
- FJK
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- May 2, 2008
- Posted
- September 26, 2008
- Terminated
- May 22, 2012
- Address
- 14143 Denver West Pkwy, Lakewood, CO, 80401-3116
Description
Gambro Cartridge Blood Set, 003410-510, is intended for single use in a hemodialysis treatment using the Phoenix and Centry system 3 Dialysis Delivery Systems.
Reason
Dialysis tubing sets may have occlusions restricting blood flow.
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.