BD 25G Spinal Needles. (Spinal Anesthesia Needle)
FDA device recall Z-0928-05 · posted 2005-06-25 · Terminated
Recall details
- Recalling firm
- Becton Dickinson & Company
- Reason for recall
- 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.
- Action taken
- The firm sent out notification letters on 3/16/2005.
- Root cause
- Other
- Status
- Terminated
- Product code
- BSP
- Quantity affected
- 801580 units
- Distribution
- The firm uses distributors and ships the product directly to over 4000 hospitals and clinics nationwide.
- Date initiated
- 2005-03-16
- Date posted
- 2005-06-25
- Date terminated
- 2005-11-07
- Location
- Franklin Lakes, NJ
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