Recall Z-0485-2018 ยท KPE Container, I.V.
Baxter Healthcare Corporation
Empty IntraVia Container with Non-DEHP Fluid Path, 500mL Containers are intended for use in the preparation and administration of drug admixtures.
| Date | Jan 11, 2018 (initiated Jul 27, 2017) |
| Status | Terminated |
| Reason | A leak may allow for microbial contamination of the sterile fluid path. |
| Root cause | Process control |
| Action | US consignees were notified via letter on July 27, 2017 and Canadian consignees were notified on July 31, 2017. Instructions included to locate and remove all affected product from the facility, contact Baxter Healthcare to arrange for return of product, complete and return the Reply Form, and to notify customers if the product was further distributed. For further questions, please call (800) 422-9837. |
| Quantity | 29,088 units |
| Distribution | Distribution in the US and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K964853 | INTRAVIA CONTAINER, EMPTY Baxter Healthcare Corp, Mar 31, 1997 |