—#156271

Product

BD 10mL Syringe Luer-Lok Tip Catalog number 301997 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.

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 #156271. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.