Z-0301-05

Baxter CAPD Solution Transfer Set for use with UV-Flash Germicidal Exchange Device, 1.2 m (48''); a sterile...

Name: Z-0301-05 Baxter CAPD Solution Transfer Set for use with UV-Flash Germicidal Exchange Device, 1.2 m (48''); a sterile...
Creator: Baxter Healthcare Renal Div
Published: 2004-11-05
License: https://open.fda.gov/license/

Baxter Healthcare Renal Div / initiated 2004-11-05 / Terminated

FDA source

Baxter Healthcare Renal Div began a recall of 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... on 2004-11-05. The reason FDA records is "Disconnection of the tubing at the clamp level of the UV Flash Transfer Set". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0301-05
Status: Terminated
Initiated: 2004-11-05
Posted: 2004-12-09
Terminated: 2006-05-16
Recalling firm: Baxter Healthcare Renal Div
Product: 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
Product code: KDJ Set, Administration, For Peritoneal Dialysis, Disposable
Reason for recall: Disconnection of the tubing at the clamp level of the UV Flash Transfer Set.
FDA 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 in commerce: 1,152 sets
Distribution: The entire lot was distributed overseas to Belgium, Sweden, Norway, the United Kingdom, Germany and France.
Product codes and lots: Product code R5C4325, lot H03L12057, expiration date 12/31/08

Product code KDJ

K883239Class IICapd Ultraviolet(u.v.) Germicidal Exchange Dev SysBaxter Healthcare Corp / cleared 1988-10-21

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)