EXACTAMIX Empty EVA Bags - 500 mL - Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a patient through an intravascular administration set.
FDA Recall Z-0364-2019 · Posted 2018-11-02
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Recalling FirmBaxter Healthcare Corporation
Recall StatusTerminated
Product CodeKPE
Date Initiated2018-09-12
Date Terminated2020-11-02
Product Quantity110,134 units
Reason for Recall
Potential ability to leak once used for compounding.
Firm 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.
Root Cause
Process control
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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