Recall Z-0507-06 ยท CAZ Anesthesia Conduction Kit
Baxter Healthcare Corp.
Baxter Continuous Epidural Anesthesia Trays that contain BD Catheter Connectors; Sterile, single use only kits containing an epidural needle, epidural catheter, glass LOR syringe and non-latex components for the preparation and insertion of the epidural needle and catheter; Assembled by Baxter Healthcare Corporation, Deerfield, IL U.S.A.
| Date | Feb 8, 2006 (initiated Jan 10, 2006) |
| Status | Terminated |
| Reason | The BD catheter connector contained in the Epidural Anesthesia Trays may not fully secure the catheter and allows the catheter to either become loose or disconnected from the connector. |
| Root cause | Other |
| Action | Baxter sent Urgent Product Recall letters dated 1/10/06 to their customers, to the attention of the Director of Anesthesia, via first class mail on the same date. The accounts were informed that the BD catheter connector in the tray may not fully secure the catheter, resulting in the possible leakage or incomplete delivery of medication. The accounts were instructed to examine their inventory for the affected lots of product, remove it from inventory and destroy it for credit. Any questions were directed to the Center for One Baxter at 1-800-422-9837. |
| Quantity | 1,070 trays |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.