Class 2 Device Recall ExactaMix

• Date Initiated by Firm: May 26, 2010
• Date Posted: August 02, 2010
• Recall Status: Terminated on August 04, 2011
• Recall Number: Z-2137-2010
• Recall Event ID: 55931
• 510(K)Number: K900585
• Product Classification: tpn bag - Product Code KPE
• Product: Exacta-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: 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: 2,017,700 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.