Recall Z-1439-04 ยท BSP Needle, Conduction, Anesthetic (W/Wo Introducer)
B. Braun Medical, Inc.
Standard and Custom Spinal Trays with 5% Lidocaine Hydrochloride 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
| K820047 | SPINOCAN SPINAL NEEDLE Burron Medical Products, Inc., Jan 25, 1982 |