Recall Z-0207-2018— Becton Dickinson & Company

Name: FDA recall Z-0207-2018
Creator: U.S. Food and Drug Administration
Published: 2017-05-31

Class II · Terminated

Class II FDA medical device recall by Becton Dickinson & Company, initiated 2017-05-31, terminated 2018-06-28. It names one FDA 510(k) clearance: K021475. Product: BD Precision Glide Needle 18G x 1 RB, Catalog 305195 Product Usage: These needles are intended for general purpose fluid injection/aspiration, infusion, venipuncture to obtain blood collection and insulin injection.. Reason: Hub damage resulting in breakage and/or leakage during use..

Recalling firm: Becton Dickinson & Company
Classification: Class II
Status: Terminated
Initiated: 2017-05-31
Terminated: 2018-06-28
Firm location: Franklin Lakes, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K021475 — BD SINGLE LUMEN NEEDLE, SYRINGE AND BLOOD COLLECTION SETBd·cleared 2002-07-19

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 Precision Glide Needle 18G x 1 RB, Catalog 305195 Product Usage: These needles are intended for general purpose fluid injection/aspiration, infusion, venipuncture to obtain blood collection and insulin injection.

Reason for recall

Hub damage resulting in breakage and/or leakage during use.

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