FDA Medical Device Recalls (openFDA)
Gambro Renal Products, Inc.: Gambro Prismaflex Hemodialysis Machine, Catalogue Number 6023014700, Gambro Dasco S.p.A, Italy.
- Recall number
- Z-0032-2007
- Recalling firm
- Gambro Renal Products, Inc.
- Product
- Gambro Prismaflex Hemodialysis Machine, Catalogue Number 6023014700, Gambro Dasco S.p.A, Italy.
- Status
- Terminated
- Initiated
- 2006-05-16
- Posted
- 2006-10-12
- Terminated
- 2012-01-03
- Reason
- A potential risk of infusing air or infusion fluid to the patient during dialysis. Also, a possibility of an incorrect scale reading of the amount of patient fluid removal.
- Root cause
- Software design
- Action
- Consignees were notified by letter on 05/16/2006.
- Quantity
- 153 units (US)
- Distribution
- Nationwide.
- Lot, serial or model codes
- Serial numbers: PA0101 to PA0681.
- 510(k) numbers
- ["K041005"]
- 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