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U.S. Department of Health and Human Services

Class 2 Device Recall TPN compounder disposable valve set

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  Class 2 Device Recall TPN compounder disposable valve set see related information
Date Initiated by Firm April 30, 2004
Date Posted July 20, 2004
Recall Status1 Terminated 3 on August 12, 2004
Recall Number Z-0980-04
Recall Event ID 29037
510(K)Number K900585  
Product Classification Set, I.V. Fluid Transfer - Product Code LHI
Product Exacta-Mix Valve Set, Six Inlet, Non-Vented, Assembled
Code Information Order No. REF: 706
Recalling Firm/
Baxa Corporation
14445 Grasslands Dr
Englewood CO 80112-7062
For Additional Information Contact
Manufacturer Reason
for Recall
A potential leak situation in the port valve assembly could result in inaccurate ingredient delivery.
FDA Determined
Cause 2
Action Consignees were notified by phone, fax and letter beginning 4/30/2004.
Quantity in Commerce 397 cases (10 per case)
Distribution Nationwide, including 6 military hospitals and two VA facilities. Foreign distribution to Argentina, Brazil, Canada, Columbia, Hong Kong, Korea, Malaysia, Mexico, Panama, Singapore, Taiwan, UK, and Venezuela.
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 = LHI and Original Applicant = BAXA CORP., SUB. OF COOK GROUP, INC.