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U.S. Department of Health and Human Services

Medical Device Recalls

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  Medical Device Recalls see related information
Date Initiated by Firm October 18, 2001
Create Date September 11, 2008
Recall Status1 Completed
Recall Number Z-0257-02
Recall Event ID 3359
Product Melt-spun Cellulose Diacetate Hemodialyzers; a single use sterile
device for hemodialysis of patients with acute or chronic renal
failure; 12 units per case; A-Series Dialyzers made from Altra Nova
Fibers, AF-Series Dialyzers made from Altra Flux Fiber and AX-
Series Dialyzers made from Altrex Fiber A-11, A-15, A-18, A-22, AF-150, AF-180, AF-220, AX-1500, AX-2200
Recalling Firm/
Baxter Healthcare Corp.
Route 120 & Wilson Road
Round Lake IL 60073-0490
Manufacturer Reason
for Recall
Hemodialyzers associated with deaths in Croatia, Spain et al
Action The U.S. accounts were telephoned on 10/18/01 and sent follow-up recall letters dated 10/18/01 via Airborne overnight mail. Global recall of the A-series dialyzers initiated on 10/17/01 via telephone calls and follow-up letters dated 10/18/01. Global recall expanded to include the AF-series dialyzers on 10/18/01 and the AX-series dialyzers on 10/19/01.
Quantity in Commerce 2435306 dialyzers worldwide
Distribution The dialyzers were distributed in the United States, Algeria, Argentina, Austria, Belgium, Bulgaria, Canada, China, Colombia, Croatia, Czech Republic, Egypt, England, Finland, France, Germany, Great Britain, Greece, Guatemala, Hong Kong, Hungary, Iran, Israel, Italy, Japan, Jordan, Korea, Latvia, Mexico, Morocco, Netherlands, Oman, Palestine, Poland, Qatar, Romania, Russia, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Tunisia, Turkey, Venezuela, Ukraine, United Arab Emirates and United Kingdom. The AX-series dialyzers were not distributed in the United States. The U.S. distribution includes the following direct sale government accounts: a) VA Medical Center, 4150 Clement St, San Francisco, CA b) VA Medical Center, 1481 W. 10th Street, Indianapolis, IN c) VA Medical Center, 3350 La Jolla Villa Dr, San Diego, CA d) VA Medical Center, 1111 E End Blvd, Wilkes Barre, PA e) VA Medical Center, 1660 S. Columbia Way, Seattle, WA f) VA Medical Center, One Jefferson Barracks Dr, St Louis, MO

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.