Z-0177-04

CA Cellulose Acetate High Efficiency Hollow Fiber Dialyzers; Model CA 210, product code 5M1736; Distributed...

Name: Z-0177-04 CA Cellulose Acetate High Efficiency Hollow Fiber Dialyzers; Model CA 210, product code 5M1736; Distributed...
Creator: Baxter Healthcare Corp.
Published: 2003-10-30
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2003-10-30 / Terminated

FDA source

Baxter Healthcare Corp. began a recall of CA Cellulose Acetate High Efficiency Hollow Fiber Dialyzers; Model CA 210, product code 5M1736; Distributed by Baxter Healthcare Corporation, Deerfield, IL... on 2003-10-30. The reason FDA records is "Use of the dialyzers may cause iritis (red-eye) patient reactions". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0177-04
Status: Terminated
Initiated: 2003-10-30
Posted: 2003-12-04
Terminated: 2005-04-13
Recalling firm: Baxter Healthcare Corporation
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
Product code: KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Reason for recall: Use of the dialyzers may cause iritis (red-eye) patient reactions.
FDA root 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.
Product codes and lots: Product code 5M1736, lot numbers A00K09, exp 10/2003; A01C04, exp 2/2004; C01A08, exp 12/2003; E01B15, exp 1/2004

Product code KDI

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)