Gambro Cartridge Blood Set, 003410-510, is intended for single use in a hemodialysis treatment using the Phoenix and Cen
FDA device recall Z-1860-2008 · posted 2008-09-26 · Terminated
Recall details
- Recalling firm
- Gambro Renal Products, Inc.
- Reason for recall
- Dialysis tubing sets may have occlusions restricting blood flow.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- FJK
- Distribution
- Nationwide Distribution --- including states of CA,GA, IL, KY, MO, NJ, NM, NY, NC, ND, PA, TN, and VA.
- Date initiated
- 2008-05-02
- Date posted
- 2008-09-26
- Date terminated
- 2012-05-22
- Location
- Lakewood, CO
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GAMBRO CARTRIDGE BLOOD SETS (K070414) | Gambro Renal Products | 2007-10-12 |