Class 2 Device Recall EXACTAMIX Empty EVA (ethylene vinyl acetate) TPN Bag

• Date Initiated by Firm: September 12, 2018
• Date Posted: November 02, 2018
• Recall Status: Terminated on November 02, 2020
• Recall Number: Z-0363-2019
• Recall Event ID: 81240
• 510(K)Number: K900585
• Product Classification: Container, I.V. - Product Code KPE
• Product: EXACTAMIX Empty EVA Bags - 250 mL Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a patient through an intravascular administration set.
• Code Information: Product Code H938737 Lot #'s: 60064550, 60070834, 60075460, 60083515, 60088184, 60089783, 60091143, 60097820, 60098862 and 60106876. **Update expansion on 02/19/2019 with additional lot numbers: 60092411, 60093840, 60096703, 60103940, 60110724, 60112088, 60116852, 60119378, 60119379, 60127187, 60128808.
• Recalling Firm/ Manufacturer: Baxter Healthcare Corporation; 1 Baxter Pkwy; Deerfield IL 60015-4625
• Manufacturer Reason for Recall: Potential ability to leak once used for compounding.
• FDA Determined Cause: Process control
• Action: An Urgent Product Recall communication will be sent to affected customers via U.S.P.S., first class mail. Baxter is asking customers to: 1. Locate and remove all affected product from your facility. 2. Contact Baxter Healthcare Center for Service to arrange for return and credit. 3. Complete the enclosed Baxter Customer Reply Form and return it to Baxter by either fax or email. Notification Effectiveness: 100%. The non-responding customers will be contacted via telephone. Expansion on 02/19/2019, Baxter notified customers (and additional customers) of recall and additional lots included.
• Quantity in Commerce: 158,163 units
• Distribution: Worldwide distribution - US Nationwide in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WV. Countries of Canada, Australia, New Zealand, China, Hong Kong, Brazil, Chile, 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.