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U.S. Department of Health and Human Services

Class 2 Device Recall Accura System for Blood Filtration

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  Class 2 Device Recall Accura System for Blood Filtration see related information
Date Initiated by Firm July 26, 2004
Date Posted August 11, 2004
Recall Status1 Terminated 3 on November 03, 2005
Recall Number Z-1338-04
Recall Event ID 29630
510(K)Number K021615  
Product Classification Dialyzer, High Permeability With Or Without Sealed Dialysate System - Product Code KDI
Product Accura System for Blood Filtration, product codes 5M5660 and ACCURA01 (international); a hemofiltration system; Baxter Healthcare Corporation, Renal Division, McGaw Park, IL 60085
Code Information 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
Recalling Firm/
Manufacturer		 Baxter Healthcare Renal Div
1620 Waukegan Rd Bldg R
Mc Gaw Park IL 60085-6730
For Additional Information Contact Center for One Baxter
800-422-9837
Manufacturer 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 Determined
Cause 2		 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KDI and Original Applicant = BAXTER HEALTHCARE CORP.
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