Recall Z-0392-2014 ยท LHI Set, I.V. Fluid Transfer
Baxter Healthcare Corp.
Baxter, VIAL-MATE Adaptor, 2B8071, Rx Only, STERILE R, Baxter Healthcare Corporation, Deerfield, IL 30015 USA The VIAL-MATE is reconstitution device labeled for use with 20 mm drug vials and 50mL, 100mL, and 250mL Single Pack Mini Bags.
| Date | Nov 26, 2013 (initiated Sep 25, 2013) |
| Status | Terminated |
| Reason | Incomplete foil seal on one lot of sterile product. |
| Root cause | Packaging process control |
| Action | Baxter Healthcare sent an Urgent Product Recall letter dated September 25, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to locate and remove all affected product from their facility, contact Baxter's Center for Service at 1-888-229-0001 to arrange for return and credit. Complete the attached Customer Reply Form and return it to Baxter by fax or email. Customers with questions were instructed to call 1-800-422-9837. For questions regarding this recall call 224-948-4770. |
| Quantity | 38,400 units |
| Distribution | Nationwide Distribution including WV, KY, IA, AR, OH, IL, IN, MI, KS, TN, WI, MN, MO. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K973654 | VIAL-MATE RECONSTITUTION DEVICE (2B8071) Baxter Healthcare Corp, Oct 24, 1997 |