Class 2 Device Recall CA 210 Dialyzers

• Date Initiated by Firm: October 30, 2003
• Date Posted: December 04, 2003
• Recall Status: Terminated on April 13, 2005
• Recall Number: Z-0177-04
• Recall Event ID: 27605
• 510(K)Number: K926567B
• Product Classification: Dialyzer, High Permeability With Or Without Sealed Dialysate System - Product Code KDI
• Product: CA Cellulose Acetate High Efficiency Hollow Fiber Dialyzers; Model CA 210, product code 5M1736; Distributed by Baxter Healthcare Corporation, Deerfield, IL 60015 USA, Made in Japan; 24 units per case
• Code Information: Product code 5M1736, lot numbers A00K09, exp 10/2003; A01C04, exp 2/2004; C01A08, exp 12/2003; E01B15, exp 1/2004
• Recalling Firm/ Manufacturer: Baxter Healthcare Corp.; Rt 120 & Wilson Rd; Round Lake IL 60073
• For Additional Information Contact: Center for One Baxter; 800-422-9837
• Manufacturer Reason for Recall: Use of the dialyzers may cause iritis (red-eye) patient reactions.
• FDA Determined Cause: Other
• Action: Recall letters dated October 30, 2003 informed the customers of the patient reactions and were provided with copies of the December 16, 1996 letter from the FDA, 'Important Information Relating to Cellulose Acetate Dialyzers'. The accounts were requested to examine their inventories for the affected lots and discontinue their use immediately.
• Quantity in Commerce: 34,865 units
• Distribution: Nationwide, Mexico, Chile, Ecuador, Argentina, Puerto Rico and Brazil.
• 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.