FDA Medical Device Recalls (openFDA)
Gambro Renal Products, Incorporated: Prismaflex System, Catalog Number 107493, Indicated for continuous solute and/or fluid removal in patients with acute renal failure or fluid overload.
- Recall number
- Z-1901-2011
- Recalling firm
- Gambro Renal Products, Incorporated
- Product
- Prismaflex System, Catalog Number 107493, Indicated for continuous solute and/or fluid removal in patients with acute renal failure or fluid overload.
- Status
- Terminated
- Initiated
- 2011-03-14
- Posted
- 2011-04-06
- Terminated
- 2011-09-01
- Reason
- Prismaflex touch screen may become unresponsive during Continuous Renal Replacement Therapy procedure.
- Root cause
- Software change control
- Action
- The firm, GAMBRO Renal Products, sent an "URGENT - MEDICAL DEVICE RECALL" letter dated March 14, 2011 to all customers. The letter described the product, problem and actions to be taken. The customers were provided with response procedures to use if the frozen screen problem occurs while using the product. The customers were instructed to closely monitor the return line for potential air and/or clots in the circuit; review the instructions provided in the attached copy of Chapter 5: Troubleshooting, "Softkeys won't work." of the Prismaflex Operators Manual in conjunction with the attached Troubleshooting Checklist; be aware if performing Manual Termination with Blood Return, air detection is not provided, and complete and return the Customer Reply Form via fax to: Regulatory Affairs at 1-866-447-4471 or 303-222-6916, or by email to: GRPRegulatory.Affairs@us.gambro.com. If you have any questions or concerns, please contact for Clinical questions: ICON 800-554-1312 (available 24/7) or your local Gambro Representative; for Technical questions: Gambro Customer Support 800-525-2623, option 2 (Available 6:00am to 5:30pm MT, Monday thru Friday).
- Quantity
- 1300 units
- Distribution
- Nationwide distribution.
- Lot, serial or model codes
- All units with Version 3.20 software.
- 510(k) numbers
- ["K072093"]
- 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