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Terminated

BD 25G Spinal Needles. (Spinal Anesthesia Needle)

FDA Recall Z-0928-05 · Posted 2005-06-25

Recalling FirmBecton Dickinson & Company
Recall StatusTerminated
Product CodeBSP
Date Initiated2005-03-16
Date Terminated2005-11-07
Product Quantity801580 units

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.

Firm Action

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

Root Cause

Other

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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