Recall Z-2747-2017— Becton Dickinson & Company

Name: FDA recall Z-2747-2017
Creator: U.S. Food and Drug Administration
Published: 2016-09-16

Class II · Terminated

Class II FDA medical device recall by Becton Dickinson & Company, initiated 2016-09-16, terminated 2018-03-20. It names one FDA 510(k) clearance: K110771. Product: BD 5ml Syringe Luer-Lok" Tip with Blunt Fill Needle 18G x 1 1/2 (1.2mm x 40mm) Catalog #305062. Reason: BD identified that several lots did not receive the specified dose of irradiation necessary to meet the Sterility Assurance Level (SAL) required..

Recalling firm: Becton Dickinson & Company
Classification: Class II
Status: Terminated
Initiated: 2016-09-16
Terminated: 2018-03-20
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

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

Reason for recall

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

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