Gambro Prismaflex Continuous Renal Replacement System, Catalog Number 602314700, Gambro Lundia AB, Sweden.
FDA device recall Z-0695-2007 · posted 2007-03-31 · Terminated
Recall details
- Recalling firm
- Gambro Renal Products, Inc.
- Reason for recall
- Under certain conditions, * an excessive amount of anticoagulant may be infused into the patient. (* interruption of a self-test by an alarm and obstruction of the access lines)
- Action taken
- Customers were notified by letter on 12/19/2006. They were told that Gambro would schedule the required upgrades to their equipment and not to use the current syringe for delivering anticoagulant.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- KDI
- Quantity affected
- 153 units (Domestic)
- Distribution
- Nationwide distribution -- including states of AL, CA, FL, GA, IN, MD, ME, MI, MS, NC, NH, NY, OH, PA, SC, TX, VA, and WI.
- Date initiated
- 2007-01-04
- Date posted
- 2007-03-31
- Date terminated
- 2012-01-03
- 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 PRISMAFLEX AND GAMBRO PRISMAFLEX M60 & M100 SETS (K041005) | Gambro Renal Products | 2004-10-07 |