Prisma continuous renal replacement system.
FDA device recall Z-1545-05 · posted 2005-10-01 · Terminated
Recall details
- Recalling firm
- Gambro Renal Products
- Reason for recall
- Critically ill patients undergoing continuous renal replacement therapy may suffer excessive fluid loss.
- Action taken
- Consignees were notified by press release and letter on 8/16/2005.
- Root cause
- Software design
- Status
- Terminated
- Product code
- KDI
- Quantity affected
- 1964 units
- Distribution
- Nationwide, including Puerto Rico and Washington, DC. Military consignees in CA and TX. VA consignees in AZ, CA, DC, FL, GA, MO, OH, OR, PA, PR, TX, UT, VA and WI. No foreign distribution by US firm.
- Date initiated
- 2005-08-16
- Date posted
- 2005-10-01
- 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 |
|---|---|---|
| PRISMA SYSTEM (K010805) | Gambro Renal Products | 2002-08-06 |
| PRISMA CFM (CONTINUOUS FLUID MANAGEMENT SYSTEM) (K993064) | Gambro Renal Care Products | 1999-10-06 |