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
This recall has been terminated (originally issued December 9, 2004).
- Company
- Baxter Healthcare Renal Div
- Recall Initiated
- November 5, 2004
- Posted
- December 9, 2004
- Terminated
- May 16, 2006
- Recall Number
- Z-0301-05
- Quantity
- 1,152 sets
- Firm Location
- Mc Gaw Park, IL
- Official Source
- View on FDA website ↗
Reason for Recall
Disconnection of the tubing at the clamp level of the UV Flash Transfer Set.
Distribution
The entire lot was distributed overseas to Belgium, Sweden, Norway, the United Kingdom, Germany and France.
Lot / Code Info
Product code R5C4325, lot H03L12057, expiration date 12/31/08
Root Cause
Other
Action Taken
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.
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