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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 setsee related information
Date Initiated by FirmApril 30, 2004
Date PostedJuly 20, 2004
Recall Status1 Terminated 3 on August 12, 2004
Recall NumberZ-0979-04
Recall Event ID 29037
510(K)NumberK900585 
Product Classification Set, I.V. Fluid Transfer - Product Code LHI
ProductExacta-Mix Valve Set, Secondary Valve Assembly
Code Information Order No. REF: 693
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 2
Other
ActionConsignees were notified by phone, fax and letter beginning 4/30/2004.
Quantity in Commerce770 cases (10 per case)
DistributionNationwide, 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 CycleTPLC 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) Database510(K)s with Product Code = LHI
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