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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 May 26, 2010
Date Posted August 02, 2010
Recall Status1 Terminated 3 on August 04, 2011
Recall Number Z-2138-2010
Recall Event ID 55931
510(K)Number K900585  
Product Classification tpn bag - Product Code KPE
Product Exacta-Mix EVA Container, Sterile R, 500 mL, Order No. REF: 138, Baxa Corporation.
Code Information All lot numbers
Recalling Firm/
Baxa Corporation
14445 Grasslands Dr
Englewood CO 80112
For Additional Information Contact
Manufacturer Reason
for Recall
Fill port cap on TPN bags may become detached prior to use, thus compromising the sterility of the fluid pathway.
FDA Determined
Cause 2
Process design
Action Consignees were notified by e-mail and Baxa Bag Product Notice letter on 05/26/2010 with instructions to not use any bags if the fill port cap is detached. Photos of a detached cap and properly attached cap were included. Defective bags could be returned to Baxa for credit. Information available at 800-678-2292.
Quantity in Commerce 3,156,850 bags
Distribution Worldwide distribution, including USA, Argentina, Australia, Bermuda, Brazil, Canada, China, Colombia, Hong Kong, Malaysia, Mexico, New Zealand, Pakistan, Panama, South Korea, Taiwan, United Kingdom, 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.