Class 2 Device Recall TPN compounder disposable valve set

• Date Initiated by Firm: April 30, 2004
• Date Posted: July 20, 2004
• Recall Status: Terminated on August 12, 2004
• Recall Number: Z-0984-04
• Recall Event ID: 29037
• 510(K)Number: K900585
• Product Classification: Set, I.V. Fluid Transfer - Product Code LHI
• Product: Exacta-Mix Valve Set, Primary Valve Assembly
• Code Information: Order No. REF: 713
• Recalling Firm/ Manufacturer: Baxa Corporation; 14445 Grasslands Dr; Englewood CO 80112-7062
• For Additional Information Contact: 303-617-2181
• Manufacturer Reason for Recall: A potential leak situation in the port valve assembly could result in inaccurate ingredient delivery.
• FDA Determined Cause: Other
• Action: Consignees were notified by phone, fax and letter beginning 4/30/2004.
• Quantity in Commerce: 1531 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