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U.S. Department of Health and Human Services

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

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  Class 2 Device Recall EXACTAMIX Empty EVA (ethylene vinyl acetate) TPN Bag see related information
Date Initiated by Firm September 12, 2018
Date Posted November 02, 2018
Recall Status1 Terminated 3 on November 02, 2020
Recall Number Z-0365-2019
Recall Event ID 81240
510(K)Number K900585  
Product Classification Container, I.V. - Product Code KPE
Product EXACTAMIX Empty EVA Bags - 1000 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 H938739 Lot #'s: 60066021, 60069101, 60072119, 60075857, 60080377, 60084632, and 60095474.  **Update expansion on 02/19/2019 with additional lot numbers: 60070846, 60081688, 60097844, 60098902, 60110761, 60110765, 60120570, 60124005, 60124006, 60124008, 60126009. 
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 2
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 136,800 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.
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