Recall Z-2165-2013 ยท LHI Set, I.V. Fluid Transfer
Baxa Corporation
Baxa Vial Adapter, 14mm - Luer Lock, Order No. REF: 90, Quantity: 50 each, Single Use. Product Code H93890. Used as a needleless access device for reconstitution and drug transfer.
| Date | Sep 6, 2013 (initiated Aug 22, 2013) |
| Status | Terminated |
| Reason | Baxter Healthcare Corporation is voluntarily recalling one lot of Baxa Vial Adapters, 14mm - Luer Lock, due to incorrect expiry date. |
| Root cause | Labeling Change Control |
| Action | An Urgent Product Recall notification was mailed to one customer via USPS First Class mail on 8/22/13. The one customer affected by this action was instructed to locate and remove the affected product from inventory and to return to Baxter for credit and/or replacement. Any customer returns received will be discarded per the Corporate Hold. |
| Quantity | 34 cases |
| Distribution | Distributed to One Customer in NC. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K900585 | TUBING SETS FOR BAXA EXACTA-MED PHARMACY PUMP Baxa Corp., Sub. of Cook Group, Inc., Apr 18, 1990 |