—#156186

Product

BD 5ml Syringe Luer-Lok" Tip with Blunt Fill Needle 18G x 1 1/2 (1.2mm x 40mm) Catalog #305062

FDA product code: FMF — Syringe, Piston
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K110771
Affected lot / code info: 6204878 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 #156186. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.