FDA Medical Device Recalls (openFDA)
Gambro Renal Products, Inc.: Gambro Prisma HF1000 preset, Part No. 8399050.
- Recall number
- Z-0706-06
- Recalling firm
- Gambro Renal Products, Inc.
- Product
- Gambro Prisma HF1000 preset, Part No. 8399050.
- Status
- Terminated
- Initiated
- 2005-10-24
- Posted
- 2006-04-05
- Terminated
- 2012-04-17
- 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.
- Lot, serial or model codes
- Lot number 05F0864P. Recall expanded on 04/13/2006 to include 05AXXXXX through 05J2796P
- 510(k) numbers
- ["K011221"]
- PMA numbers
- not on file
- Product code
- KDI
- Firm FEI
- 1713683
- Firm city
- Lakewood
- Firm state
- CO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28