Recall Z-0301-05 ยท KDJ Set, Administration, For Peritoneal Dialysis, Disposable
Baxter Healthcare Renal Div
Baxter CAPD Solution Transfer Set for use with UV-Flash Germicidal Exchange Device, 1.2 m (48''); a sterile set consisting of a bag connector (spike connector), on-off clamp assembly, tubing and double sealing male Luer lock connector; Baxter Healthcare Corporation, Renal Division, McGaw Park, IL 60085; product code R5C4325
| Date | Dec 9, 2004 (initiated Nov 5, 2004) |
| Status | Terminated |
| Reason | Disconnection of the tubing at the clamp level of the UV Flash Transfer Set. |
| Root cause | Other |
| Action | Recall by letter dated 11/05/04. The customers were instructed to stop using this lot of product, return any stocks of the lot back to Baxter, and that replacement of the patient''s set be completed at the dialysis center. |
| Quantity | 1,152 sets |
| Distribution | The entire lot was distributed overseas to Belgium, Sweden, Norway, the United Kingdom, Germany and France. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K883239 | CAPD ULTRAVIOLET(U.V.) GERMICIDAL EXCHANGE DEV SYS Baxter Healthcare Corp, Oct 21, 1988 |