Recalls / —
—#30168
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
- FDA product code
- KDI — Dialyzer, High Permeability With Or Without Sealed Dialysate System
- Device class
- Class 2
- Medical specialty
- Gastroenterology, Urology
- Affected lot / code info
- Product code 5M1736, lot numbers A00K09, exp 10/2003; A01C04, exp 2/2004; C01A08, exp 12/2003; E01B15, exp 1/2004
Why it was recalled
Use of the dialyzers may cause iritis (red-eye) patient reactions.
Root cause (FDA determination)
Other
Action the firm took
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.
Recalling firm
- Firm
- Baxter Healthcare Corp. Rt
- Address
- 120 & Wilson Rd, Round Lake, Illinois 60073
Distribution
- Distribution pattern
- Nationwide, Mexico, Chile, Ecuador, Argentina, Puerto Rico and Brazil.
Timeline
- Recall initiated
- 2003-10-30
- Posted by FDA
- 2003-12-04
- Terminated
- 2005-04-13
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #30168. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.