Recall Z-0084-2015 ยท KPE Container, I.V.
Baxter Healthcare Corp
Baxter 2B8011 Empty INTRA VIA Container with PVC Ports, Sterile fluid path, 150 ml, Admixture Products and Accessories. The lntraVia Empty Plastic Container is intended for use in the preparation and administration of drug admixtures.
| Date | Oct 31, 2014 (initiated Sep 16, 2014) |
| Status | Terminated |
| Reason | Particulate matter found inside the fluid path. |
| Root cause | Equipment maintenance |
| Action | Baxter issued a letter to their consignees stating the following: Baxter is requesting that you take the following actions: Action to be taken if product was purchased directly from Baxter. 1. Locate and remove all affected product from all locations in your facility (the product code and lot numbers can be found on the individual product package or shipping carton). 2. Contact Baxter Healthcare Center for Service to arrange for return and credit. The Center for Service can be reached at 888-229-0001 between the hours of 7:00 am and 6:00 pm Central Time. Please have your Baxter eight-digit sh |
| Quantity | 94,224 |
| Distribution | Nationwide Distribution including Puerto Rico, and the country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K964853 | INTRAVIA CONTAINER, EMPTY Baxter Healthcare Corp, Mar 31, 1997 |