Recall Z-1099-05 ยท FPA Set, Administration, Intravascular
Baxter Healthcare Corp.
Baxter Interlink System Minivolume Extension Set, product code 1C8290; 11'', 0.86 mL Vol., with 2 injection sites and a male Luer Lock adapter; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A.
| Date | Aug 6, 2005 (initiated Jul 6, 2005) |
| Status | Terminated |
| Reason | Leaks and disconnection between the bifurcated Y-site and the set tubing may occur and result in underdelivery of medication, blood loss, and a breach of the sterile fluid pathway. |
| Root cause | Other |
| Action | Baxter sent Urgent Product Recall letters dated 7/6/05 to their customers, to the attention of the Director of Materials Management, via first class mail on the same date. The accounts were informed of the complaints of leaks and disconnection between the bifurcated Y-site and the set tubing, resulting in the possible under delivery of medication, blood loss and a breach of the sterile fluid pathway. The accounts were instructed to examine their inventory for the affected lots of product, remove it from inventory and return it to Baxter for credit. Any questions were directed to the Center fo |
| Quantity | 18,816 sets |
| Distribution | Arizona, Georgia, Illinois, Michigan, Ohio, Pennsylvania, South Carolina and Texas. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K925126 | INTERLINK(TM) INJECTION SITE Baxter Healthcare Corp, Jun 18, 1993 |