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U.S. Department of Health and Human Services

Class 2 Device Recall Container, IV

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  Class 2 Device Recall Container, IV see related information
Date Initiated by Firm March 08, 2011
Date Posted April 12, 2011
Recall Status1 Terminated 3 on March 23, 2012
Recall Number Z-1967-2011
Recall Event ID 58304
510(K)Number K900585  
Product Classification Set, i.V. Fluid transfer - Product Code LHI
Product ExactaMix EVA Container, 3000mL, REF: 741, Sterile R, Baxa Corporation, Englewood, CO 80112.

A plastic container used to hold large-volume sterile solutions to be administered to a patient through an intravascular administration set
Code Information All codes sold since 7/23/2009.
Recalling Firm/
Manufacturer		 Baxa Corporation
14445 Grasslands Dr
Englewood CO 80112
For Additional Information Contact
303-617-2242
Manufacturer Reason
for Recall		 TPN bags may leak during filling operation, due to bag manufacturing error.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action The firm, BAXA, sent a "ExactaMix Bag Product Notice" dated March 8, 2011 to its customers. The notice described the product, problem and actions to be taken. The customers were instructed to do the following: If they do not intend to use the manual addition port, verify that the cap is firmly seated onto the port by gently tugging on the cap. If they do intend to use the manual addition port, they should snap off the additive port cap prior to compounding the bag. If they encounter a faulty additive port, contact Baxa Technical Support to receive credit and/or replacement on defective product only. To return affected bags, follow the instructions provided in the notice if the bags were purchased directly from Baxa or purchased from wholesaler, distributor or other 3rd party vendor. Additional copies of the return form can be retrieved by going to www.baxa.com/ebug OR by calling Baxa Technical Support at 800-678-2292. If you have any questions or concerns, contact the Sr. Vice President, Quality and Regulatory at (303) 400-2838 or Baxa Technical Support at 800-678-2292.
Quantity in Commerce 336,650 bags
Distribution Worldwide distribution: USA (nationwide) and countries including: Argentina, Australia, Bermuda, Brazil, Canada, Chile, China, Colombia, Hong Kong, Ireland, Japan, Malaysia, Mexico, New Zealand, Panama, Puerto Rico, Singapore, South Korea, Taiwan, UK, Uruguay, 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 and Original Applicant = BAXA CORP., SUB. OF COOK GROUP, INC.
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