Gambro Renal Products, Inc. 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
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
Gambro Renal Products, Inc.
Lot Codes / Batch Numbers
Serial numbers: 04P158215 and below, 03P158XXX (all lots)
Products Sold
Serial numbers: 04P158215 and below, 03P158XXX (all lots)
Gambro Renal Products, Inc. is recalling Gambro Cartridge Blood Set, 003410-510, is intended for single use in a hemodialysis treatment using due to Dialysis tubing sets may have occlusions restricting blood flow.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Dialysis tubing sets may have occlusions restricting blood flow.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026