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Terminated

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

FDA Recall Z-0177-04 · Posted 2003-12-04

Recalling FirmBaxter Healthcare Corp.
Recall StatusTerminated
Product CodeKDI
Date Initiated2003-10-30
Date Terminated2005-04-13
Product Quantity34,865 units

Reason for Recall

Use of the dialyzers may cause iritis (red-eye) patient reactions.

Firm 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.

Root Cause

Other

Distribution Pattern

Nationwide, Mexico, Chile, Ecuador, Argentina, Puerto Rico and Brazil.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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