—#156187

Product

BD SafetyGlide" Injection Needle Catalog #305917 The SafetyGlide " needle is intended to be used for general purpose injection, aspiration of fluids from parts of the body below the surface of the skin, injection into intravenous ports and tubings external to the patient. The needlestick prevention feature of the device contains a mechanism that covers the needlepoint after use. In the activated position the needle cover guards against accidental needle sticks during normal handling and disposal of the used needle/syringe combination

FDA product code: FMI — Needle, Hypodermic, Single Lumen
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K951254
Affected lot / code info: 6022838 2021-01

Why it was recalled

BD identified that several lots did not receive the specified dose of irradiation necessary to meet the Sterility Assurance Level (SAL) required.

Root cause (FDA determination)

Process control

Action the firm took

BD sent recall letter/return response form on 9/16/2016.

Recalling firm

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

Distribution

Distribution pattern: Nationwide Distribution

Timeline

Recall initiated: 2016-09-16
Terminated: 2018-03-20
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #156187. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.