Recall Z-0177-04 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Baxter Healthcare Corp.
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
| Date | Dec 4, 2003 (initiated Oct 30, 2003) |
| Status | Terminated |
| Reason | Use of the dialyzers may cause iritis (red-eye) patient reactions. |
| 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 | 34,865 units |
| Distribution | Nationwide, Mexico, Chile, Ecuador, Argentina, Puerto Rico and Brazil. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.