Recall Z-1936-2016— Becton Dickinson & Company

Name: FDA recall Z-1936-2016
Creator: U.S. Food and Drug Administration
Published: 2016-03-25

Class II · Terminated

Class II FDA medical device recall by Becton Dickinson & Company, initiated 2016-03-25, terminated 2017-04-03. It names one FDA 510(k) clearance: K110771. Product: Henry Schein Single Use Syringe Luer-Lock, 10 mL, Intended for use by health care professionals for general purpose fluid aspiration/injection. Reason: BD 10 mL Syringe Luer-Lok Tip with BD PrecisionGlide Needle 21G x 1 (0.8 mm x 25 mm) and Henry Schein 10 mL Single Use Syringe Luer-Lock are being recalled due to possible adulteration and non-conforming manufacturing practices..

Recalling firm: Becton Dickinson & Company
Classification: Class II
Status: Terminated
Initiated: 2016-03-25
Terminated: 2017-04-03
Firm location: Franklin Lakes, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K110771 — BD SINGLE USE, HYPODERMIC SYRINGEBecton, Dickinson and Company·cleared 2011-05-13

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Henry Schein Single Use Syringe Luer-Lock, 10 mL, Intended for use by health care professionals for general purpose fluid aspiration/injection

Reason for recall

BD 10 mL Syringe Luer-Lok Tip with BD PrecisionGlide Needle 21G x 1 (0.8 mm x 25 mm) and Henry Schein 10 mL Single Use Syringe Luer-Lock are being recalled due to possible adulteration and non-conforming manufacturing practices.

Data sourced from openFDA. This site is unofficial and independent of the FDA.