Z-1380-05

Accura System for Blood Filtration, product codes 5M5660 and ACCURA01 (international); a hemofiltration...

Name: Z-1380-05 Accura System for Blood Filtration, product codes 5M5660 and ACCURA01 (international); a hemofiltration...
Creator: Baxter Healthcare Renal Div
Published: 2005-07-13
License: https://open.fda.gov/license/

Baxter Healthcare Renal Div / initiated 2005-07-13 / Terminated / root cause: design

FDA source

Baxter Healthcare Renal Div began a recall of Accura System for Blood Filtration, product codes 5M5660 and ACCURA01 (international); a hemofiltration system; Baxter Healthcare Corporation, Renal Division... on 2005-07-13. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1380-05
Status: Terminated
Initiated: 2005-07-13
Posted: 2005-08-18
Terminated: 2008-10-29
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
Product code: KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Reason for recall: 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 tag: design
FDA 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 in commerce: 264 units
Distribution: Nationwide and internationally to China and Belgium
Product codes and lots: All serial numbers

Product code KDI

K021615Class IIBaxter Accura System, Model 5M5660Baxter Healthcare Corp / cleared 2002-11-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)