FDA Medical Device Recalls (openFDA)
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
- Recall number
- Z-0301-05
- 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
- Status
- Terminated
- Initiated
- 2004-11-05
- Posted
- 2004-12-09
- Terminated
- 2006-05-16
- 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.
- Lot, serial or model codes
- Product code R5C4325, lot H03L12057, expiration date 12/31/08
- 510(k) numbers
- ["K883239"]
- PMA numbers
- not on file
- Product code
- KDJ
- Firm FEI
- 3000210122
- Firm city
- Park
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28