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U.S. Department of Health and Human Services

Class 2 Device Recall Baxter CAPD Solution Transfer Set for use with UVFlash

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  Class 2 Device Recall Baxter CAPD Solution Transfer Set for use with UVFlash see related information
Date Initiated by Firm November 05, 2004
Date Posted December 09, 2004
Recall Status1 Terminated 3 on May 16, 2006
Recall Number Z-0301-05
Recall Event ID 30495
510(K)Number K883239  
Product Classification Set, Administration, For Peritoneal Dialysis, Disposable - Product Code KDJ
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
Code Information Product code R5C4325, lot H03L12057, expiration date 12/31/08
Recalling Firm/
Manufacturer		 Baxter Healthcare Renal Div
1620 Waukegan Rd Bldg R
Mc Gaw Park IL 60085-6730
For Additional Information Contact Center for One Baxter
800-422-9837
Manufacturer Reason
for Recall		 Disconnection of the tubing at the clamp level of the UV Flash Transfer Set.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KDJ and Original Applicant = BAXTER HEALTHCARE CORP.
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