Recall Z-0132-2016 ยท FPA Set, Administration, Intravascular
Baxter Healthcare Corp
ONE-LINK NON-DEHP Y-TYPE MICROBORE CATHETER EXTENSION SET NEEDLE-FREE IV CONNECTOR WITH NEUTRAL FLUID DISPLACEMENT
| Date | Oct 16, 2015 (initiated May 21, 2015) |
| Status | Terminated |
| Reason | Potential for a leak at the tubing to luer bond. |
| Root cause | Packaging |
| Action | Baxter sent their consignees a recall letter dated 05/21/2015 with the following instructions: Actions to betaken if product was purchased directly from Baxter : 1. Locate and remove all affected product from your facility. The product code and lot number can be found on the individual product or shipping carton. 2. Contact Baxter Healthcare Center for Service to arrange for return and credit. Baxter Healthcare Center for Service can be reached at 888-229-0001 between the hours of 7:00 am and 6:00 pm Central Time, Monday through Friday. Please have your Baxter 8-digit ship-to account number, |
| Quantity | 23,600 |
| Distribution | Domestic Only |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K132734 | NEUTRAL LUER ACTIVATED DEVICE (ONE-LINK NEEDLE-FREE IV CONNECTOR) AND EXTENSION SETS Baxter Healthcare Corp, Oct 8, 2013 |