Accura System for Blood Filtration, product codes 5M5660 and ACCURA01 (international); a hemofiltration system; Baxter Healthcare Corporation, Renal Division, McGaw Park, IL 60085
This recall has been terminated (originally issued August 11, 2004).
- Company
- Baxter Healthcare Renal Div
- Recall Initiated
- July 26, 2004
- Posted
- August 11, 2004
- Terminated
- November 3, 2005
- Recall Number
- Z-1338-04
- Quantity
- 85 units
- Firm Location
- Mc Gaw Park, IL
- Official Source
- View on FDA website ↗
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
Distribution
Nationwide and internationally to Belgium, China and Hong Kong
Lot / Code Info
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
Root Cause
Other
Action Taken
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.