Recall Z-1440-04 ยท BSP Needle, Conduction, Anesthetic (W/Wo Introducer)
B. Braun Medical, Inc.
Standard and Custom Spinal Trays with 7.5% Dextrose Injection USP 2 ml ampul
| Date | Sep 9, 2004 (initiated Jul 6, 2004) |
| Status | Terminated |
| Reason | drug ampuls in kits contain particulates |
| Root cause | Other |
| Action | The recalling firm/kit manufacturer issued a recall letter dated 7/8/04 to its customers informing them of the problem and to return the product. |
| Quantity | 2261 cases |
| Distribution | The products were shipped to 145 medical facilities and 79 distributors nationwide. The products were also shipped to 6 government accounts in FL, NC, NY, OH, and PA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K932569 | PENCIL POINT SPINAL NEEDLE AND TRAY B. Braun of America, Inc., Jan 26, 1994 |