Class 2 Device Recall ExactaMix

• Date Initiated by Firm: November 12, 2009
• Date Posted: March 09, 2010
• Recall Status: Terminated 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/ Manufacturer: Baxa Corporation; 14445 Grasslands Dr; Englewood CO 80112
• For Additional Information Contact: 303-690-4204
• Manufacturer Reason for Recall: TPN bags may leak fluid due to inadequate sealing.
• FDA Determined Cause: 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.