Recall Z-0607-2016 ยท NEP System/Device, Pharmacy Compounding
Baxter Healthcare Corp.
Baxter CLEARLINK System, Blood Bag Spike Adapter, Luer Activated Valve for I.C. Access, 1C8687, Product Usage: C8687: An accessory to transfer a medicinal product from one container to another container.
| Date | Nov 30, 2015 |
| Status | Terminated |
| Reason | Potential for dark loose particulate matter (400 microns or smaller) on the spike of the spike adapter or solution set. |
| Root cause | Under Investigation by firm |
| Action | Baxter sent an Urgent Product Recall letter by letter on 11/30/2015 to affected customers. The recall was extended to the consumer/user level. The letter instructed customers to locate and remove all affected product, contact Baxter Healthcare Center for Service to arrange for return of affected products and credit and complete the enclosed Baxter Customer Reply Form and return it to Baxter by either fax or scanned email. |
| Quantity | 77,136 units |
| Distribution | US Nationwide Distribution and the country of Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.