Recall Z-0366-2019 ยท KPE Container, I.V.
Baxter Healthcare Corporation
EXACTAMIX Empty EVA Bags - 2000 mL Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a patient through an intravascular administration set.
| Date | Nov 2, 2018 (initiated Sep 12, 2018) |
| Status | Terminated |
| Reason | Potential ability to leak once used for compounding. |
| Root 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 | 456,071 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 Zeal |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K900585 | TUBING SETS FOR BAXA EXACTA-MED PHARMACY PUMP Baxa Corp., Sub. of Cook Group, Inc., Apr 18, 1990 |