FDA Medical Device Recalls (openFDA)
Baxter Healthcare Renal Div: Accura System for Blood Filtration, product codes 5M5660 and ACCURA01 (international); a hemofiltration system; Baxter Healthcare Corporation, Renal Division, McGaw Park, IL 60085, manufactured in Germany
- Recall number
- Z-1380-05
- Recalling firm
- Baxter Healthcare Renal Div
- Product
- Accura System for Blood Filtration, product codes 5M5660 and ACCURA01 (international); a hemofiltration system; Baxter Healthcare Corporation, Renal Division, McGaw Park, IL 60085, manufactured in Germany
- Status
- Terminated
- Initiated
- 2005-07-13
- Posted
- 2005-08-18
- Terminated
- 2008-10-29
- Reason
- In the event therapy is terminated, as part of routine instrument programming or therapy maintenance, the Accura instrument may experience difficulty in performing a successful self-test (failure) upon an immediate attempt to restart therapy
- Root cause
- Device Design
- Action
- Baxter sent Important Product Information letters dated 7/13/05 to all Accura device customers, to the attention of the Director of Nursing, via first class mail. The letter informed the accounts of the on-going investigation into the potential self-test failure associated with the Accura instrument, and provided the customers with steps to follow if they encounter failed instrument self-tests. These guidance steps include: 1) Place the instrument into 'stand-by' mode. Generally, 15 minutes in 'stand-by' mode is sufficient to allow successful instrument self-test procedures. Enter 'stand-by' mode by turning off the power by using the upper power switch, or by selecting 'Accura off' from the user interface. Avoid selecting 'Next treatment' as this immediately puts the Accura into self-test mode. 2) After 15 minute, turn the power on. 3) After successful completion of self-test, resume therapy per the Accura Operator's Manual. 4) If the instrument still does not complete a successful self-test, additional time in 'stand-by' mode may be required. Repeat steps 1-3. 5) If repeated attempts do not yield a successful calibration test, then remove the instrument from service and contact Baxter Global Technical Services. Any questions were referred to the Center for One Baxter at 1-800-422-9837.
- Quantity
- 264 units
- Distribution
- Nationwide and internationally to China and Belgium
- Lot, serial or model codes
- All serial numbers
- 510(k) numbers
- ["K021615"]
- PMA numbers
- not on file
- Product code
- KDI
- Firm FEI
- 3000210122
- Firm city
- Park
- Firm state
- IL
- 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