Gambro Prisma M100 preset, Part No. 8353486.
FDA device recall Z-0705-06 · posted 2006-04-05 · Terminated
Recall details
- Recalling firm
- Gambro Renal Products, Inc.
- Reason for recall
- After dialysis machine is disconnected from the patient, blood leakage may occur while unloading the tubing sets from the machine.
- Action taken
- Recall information was forwarded to all Gambro Sale Organizations. Notification was sent to all US consignees on November 2nd and November 3rd, 2005.
- Root cause
- Other
- Status
- Terminated
- Product code
- KDI
- Quantity affected
- 28277 units
- Distribution
- Nationwide, including VA facilities in AZ, CA, DC, FL, GA, MI, MO, NJ, NY, OH, OR, PA, PR, TX, UT, VA, WI. Military distribution to CA and TX. Foreign distribution to Australia, Canada, Denmark, Franc
- Date initiated
- 2005-10-24
- Date posted
- 2006-04-05
- Date terminated
- 2012-04-17
- 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 M60/M100 SETS (K032431) | Gambro, Inc. | 2003-09-15 |
| HOSPAL MULTIFLOW 100, MULTIFLOW 100 KITS A0 (A0,A0/B AND A0/0), MULTIFLOW 100 KITS B22 (B22,B22/B, & B22/0) (K980386) | Gambro Healthcare | 1999-02-24 |
| PRISMA CFM (CONTINUOUS FLUID MANAGEMENT SYSTEM) (K981681) | Gambro Healthcare | 1998-08-11 |