Gambro Renal Products, Inc. Gambro Prisma HF1000 preset, Part No. 8399050. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Gambro Prisma HF1000 preset, Part No. 8399050.
Brand
Gambro Renal Products, Inc.
Lot Codes / Batch Numbers
Lot number 05F0864P. Recall expanded on 04/13/2006 to include 05AXXXXX through 05J2796P
Products Sold
Lot number 05F0864P. Recall expanded on 04/13/2006 to include 05AXXXXX through 05J2796P
Gambro Renal Products, Inc. is recalling Gambro Prisma HF1000 preset, Part No. 8399050. due to After dialysis machine is disconnected from the patient, blood leakage may occur while unloading the tubing sets from the machine.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
After dialysis machine is disconnected from the patient, blood leakage may occur while unloading the tubing sets from the machine.
Recommended Action
Per FDA guidance
Recall information was forwarded to all Gambro Sale Organizations. Notification was sent to all US consignees on November 2nd and November 3rd, 2005.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026