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U.S. Department of Health and Human Services

Class 2 Device Recall ExactaMix

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  Class 2 Device Recall ExactaMix see related information
Date Initiated by Firm November 12, 2009
Date Posted March 09, 2010
Recall Status1 Terminated 3 on February 24, 2011
Recall Number Z-1030-2010
Recall Event ID 53893
510(K)Number K900585  
Product Classification total parenteral nutrition bag - Product Code KPE
Product Exacta Mix TPN (total parenteral nutrition) Bag, Model 738, 500mL, Baxa Corporation.
Code Information Lot numbers: 738391, 738392.
Recalling Firm/
Baxa Corporation
14445 Grasslands Dr
Englewood CO 80112
For Additional Information Contact
Manufacturer Reason
for Recall
TPN bags may leak fluid due to inadequate sealing.
FDA Determined
Cause 2
Process control
Action Consignees were notified by Baxa Urgent Exactamix Bag Recall letter on 11/12/2009 and then again on 11/17/2009 when more lots were found to be affected. Instructions were to stop use and return all affected product to Baxa. More information is available at 800-678-2292.
Quantity in Commerce 646/50 bag cases
Distribution Worldwide distribution, including USA, Argentina, Australia, Bermuda, Brazil, Canada, Chile, China, Colombia, Hong Kong, Japan, Malaysia, Mexico, New Zealand, Panama, Peru, Singapore, South Korea, Taiwan, and Uruguay.
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 = KPE and Original Applicant = BAXA CORP., SUB. OF COOK GROUP, INC.