Z-1338-04

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

Name: Z-1338-04 Accura System for Blood Filtration, product codes 5M5660 and ACCURA01 (international); a hemofiltration...
Creator: Baxter Healthcare Renal Div
Published: 2004-07-26
License: https://open.fda.gov/license/

Baxter Healthcare Renal Div / initiated 2004-07-26 / Terminated

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 2004-07-26. The reason FDA records is "The Accura machine display screen may go blank during patient treatment. There is a potential risk to the patient in that the operator may try to manipulate the controls in response to a blank screen, which could affect...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1338-04
Status: Terminated
Initiated: 2004-07-26
Posted: 2004-08-11
Terminated: 2005-11-03
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
Product code: KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Reason for recall: The Accura machine display screen may go blank during patient treatment. There is a potential risk to the patient in that the operator may try to manipulate the controls in response to a blank screen, which could affect the current patient's treatment
FDA root cause: Other
Action: Baxter sent an Urgent Device Correction letter dated 7/26/04 to the direct accounts on the same date, to the attention of the Hemodialysis Unit and Hospital Administrator. The letters informed the accounts of the potential problem and provided instructions on the procedure to follow in the event the screen goes blank during patient use. Any questions were directed to Baxter Instrument Services at 1-800-553-6898, select prompt 3, option 4.
Quantity in commerce: 85 units
Distribution: Nationwide and internationally to Belgium, China and Hong Kong
Product codes and lots: product code 5M5660, serial numbers 551-556, 569, 570, 582-587, 600-604, 623, 628, 649, 650, 656-658, 667-670, 677, 685-688, 695-697, 709-712, 719-722, 729, 730, 732, 740, 741 Product code ACCURA01: serial numbers 519, 520, 532-534, 536-541, 550, 557-560, 571-574, 579-581, 588, 589, 599, 617, 659-661, 676, 678, 679

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)