—#38306

Product

BD 25G Spinal Needles. (Spinal Anesthesia Needle)

FDA product code: BSP — Needle, Conduction, Anesthetic (W/Wo Introducer)
Device class: Class 2
Medical specialty: Anesthesiology
Affected lot / code info: Reorder Number, Lot Number: 400440, 4275101; 400440, 4282078; 400440, 4317744; 400479, 3196624; 400479, 4161815; 400479, 4254414; 400479, 4324795; 400496, 4173091; 400590, 3191978; 400590, 4121350; 400621, 4146482; 401586, 3182399; 405078, 3196618; 405078, 4169804; 405078, 4194109; 405078, 4268754; 405078, 4282079; 405078, 4324791; 405078, 4349021; 405138, 4173087; 405138, 4181398; 405140, 3224096; 405140, 4110295; 405140, 4237191; 405140, 4295872, 405140, 4314481; 405140, 4336365; 405170, 4201356; 405170, 4201357 405180, 4096782; 405180, 4145523; 405180, 4148675; 405234, 3174061; 405234, 4062807; 405234, 4105111; 405234, 4163586; 405234, 4265265; 405234, 4282715; 405234, 4282716; 405234, 4314480; 405234, 4358850; 409442, 3174062; 409442, 3226365; 409442, 4110275; 409442, 4121348; 409442, 4230810; 409442, 4230813; 409442, 4257418; 409442, 4300308; 409442, 4320423; 409442, 4329215; 409442, 4349941.

Why it was recalled

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 (FDA determination)

Other

Action the firm took

The firm sent out notification letters on 3/16/2005.

Recalling firm

Firm: Becton Dickinson & Company
Address: 1 Becton Dr, Franklin Lakes, New Jersey 07417-1815

Distribution

Distribution pattern: The firm uses distributors and ships the product directly to over 4000 hospitals and clinics nationwide.

Timeline

Recall initiated: 2005-03-16
Posted by FDA: 2005-06-25
Terminated: 2005-11-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #38306. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.