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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 ExactaMixsee related information
Date Initiated by FirmMay 26, 2010
Date PostedAugust 02, 2010
Recall Status1 Terminated 3 on August 04, 2011
Recall NumberZ-2137-2010
Recall Event ID 55931
510(K)NumberK900585 
Product Classification tpn bag - Product Code KPE
ProductExacta-Mix EVA Container, Sterile R, 250 mL, Order No. REF: 137, Baxa Corporation.
Code Information All lot numbers
Recalling Firm/
Manufacturer		 Baxa Corporation
14445 Grasslands Dr
Englewood CO 80112
For Additional Information Contact
303-617-2234
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
ActionConsignees 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 Commerce2,017,700 bags
DistributionWorldwide 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 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 = KPE
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