Accura System for Blood Filtration, product codes 5M5660 and ACCURA01 (international); a hemofiltration system; Baxter Healthcare Corporation, Renal Division, McGaw Park, IL 60085
FDA Recall Z-1338-04 · Posted 2004-08-11
Recalling FirmBaxter Healthcare Renal Div
Recall StatusTerminated
Product CodeKDI
Date Initiated2004-07-26
Date Terminated2005-11-03
Product Quantity85 units
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
Firm 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.
Root Cause
Other
Distribution Pattern
Nationwide and internationally to Belgium, China and Hong Kong
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.