Recall Z-0928-05 ยท BSP Needle, Conduction, Anesthetic (W/Wo Introducer)
Becton Dickinson & Company
BD 25G Spinal Needles. (Spinal Anesthesia Needle)
| Date | Jun 25, 2005 (initiated Mar 16, 2005) |
| Status | Terminated |
| Reason | A significant level of 25G spinal needle hub leakage complaints was observed. Subsequent investigation found the leakage to be attributable to improper formation of the spinal needle hub, specifically an undersized taper and the prescence of a slight sink in the taper surface. |
| Root cause | Other |
| Action | The firm sent out notification letters on 3/16/2005. |
| Quantity | 801580 units |
| Distribution | The firm uses distributors and ships the product directly to over 4000 hospitals and clinics nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.