—#167909

Product

EXACTAMIX Empty EVA Bags - 3000 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 product code: KPE — Container, I.V.
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K900585
Affected lot / code info: Product Code H938741 Lot #'s: 60056339, 60066281, 60066284, 60066289, 60073320, 60099757, and 60103967. **Update expansion on 02/19/2019 additional lot numbers: 60055892, 60064600, 60078408, 60091166, 60094120, 60094126, 60099759, 60101131, 60101132, 60101135, 60101136, 60102485, 60103966, 60105206, 60105404, 60106918, 60117111, 60117113, 60117116, 60120934, 60120936, 60120938, 60120939, 60122729, 60122730, 60122731, 60128813, 60128814, 60128815, 60131891, 60132230, 60132231.

Why it was recalled

Potential ability to leak once used for compounding.

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Baxter Healthcare Corporation
Address: 1 Baxter Pkwy, Deerfield, Illinois 60015-4625

Distribution

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.

Timeline

Recall initiated: 2018-09-12
Posted by FDA: 2018-11-02
Terminated: 2020-11-02
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #167909. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.