Recall Z-0706-06 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Gambro Renal Products, Inc.
Gambro Prisma HF1000 preset, Part No. 8399050.
| Date | Apr 5, 2006 (initiated Oct 24, 2005) |
| Status | Terminated |
| Reason | After dialysis machine is disconnected from the patient, blood leakage may occur while unloading the tubing sets from the machine. |
| Root cause | Other |
| Action | Recall information was forwarded to all Gambro Sale Organizations. Notification was sent to all US consignees on November 2nd and November 3rd, 2005. |
| Quantity | 1665 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, France, Germany, Hungary, UK. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K011221 | PRISMA HF 1000 SET, PRISMA HF 1000 PRE-SET Gambro Renal Products, Oct 31, 2001 |