CA Cellulose Acetate High Efficiency Hollow Fiber Dialyzers; Model CA 210, product code 5M1736; Distributed by Baxter He
FDA device recall Z-0177-04 · posted 2003-12-04 · Terminated
Recall details
- Recalling firm
- Baxter Healthcare Corp.
- Reason for recall
- Use of the dialyzers may cause iritis (red-eye) patient reactions.
- Action taken
- 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
- Status
- Terminated
- Product code
- KDI
- Quantity affected
- 34,865 units
- Distribution
- Nationwide, Mexico, Chile, Ecuador, Argentina, Puerto Rico and Brazil.
- Date initiated
- 2003-10-30
- Date posted
- 2003-12-04
- Date terminated
- 2005-04-13
- Location
- Round Lake, IL
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