—#156191

Product

BD 3ml Syringe Luer-Lok" Tip Catalog 309657 The BD Single Use, Hypodermic Syringe is intended for use by health care professionals for general purpose fluid aspiration/injection

FDA product code: FMF — Syringe, Piston
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K110771
Affected lot / code info: 6061746 2021-02 6082982 2021-02 6089821 2021-03 6117858 2021-04 6117863 2021-04 6117889 2021-04 6117891 2021-04 6146962 2021-04 6173697 2021-05 6173767 2021-06 6173779 2021-06 6208614 2021-07

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 of 10-6.

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 #156191. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.