Z-0706-06

Gambro Prisma HF1000 preset, Part No. 8399050

Name: Z-0706-06 Gambro Prisma HF1000 preset, Part No. 8399050
Creator: Gambro Renal Products, Inc.
Published: 2005-10-24
License: https://open.fda.gov/license/

Gambro Renal Products / initiated 2005-10-24 / Terminated

FDA source

Gambro Renal Products, Inc. began a recall of Gambro Prisma HF1000 preset, Part No. 8399050 on 2005-10-24. The reason FDA records is "After dialysis machine is disconnected from the patient, blood leakage may occur while unloading the tubing sets from the machine". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0706-06
Status: Terminated
Initiated: 2005-10-24
Posted: 2006-04-05
Terminated: 2012-04-17
Recalling firm: Gambro Renal Products
Product: Gambro Prisma HF1000 preset, Part No. 8399050.
Product code: KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Reason for recall: After dialysis machine is disconnected from the patient, blood leakage may occur while unloading the tubing sets from the machine.
FDA 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 in commerce: 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.
Product codes and lots: Lot number 05F0864P. Recall expanded on 04/13/2006 to include 05AXXXXX through 05J2796P

Product code KDI

K011221Class IIPrisma HF 1000 Set, Prisma HF 1000 Pre-SetGambro Renal Products / cleared 2001-10-31

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)