Medical device recalls Moderate risk

Becton Dickinson & Company recalls BD 10 mL Syringe BD Luer-Lok Tip with Blunt Plastic Cannula, Not for Skin Injection ; Catalog #303348, BD 10 mL Syringe…

Recall date
December 19, 2014
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1055-2015
FDA classification
Class II
Brand / firm
Becton Dickinson & Company
Sold / distributed
US Nationwide Distribution

Why it was recalled

The stopper of the 10mL BD Luer-Lok syringe is not properly seated in the syringe.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

BD 10 mL Syringe BD Luer-Lok Tip with Blunt Plastic Cannula, Not for Skin Injection ; Catalog #303348, BD 10 mL Syringe Luer-Lok Tip with Blunt Fill Needle 18G x 1 1/2 (1.2mm x 40 mm), not for skin injection; Catalog #305064 BD 10 mL Syringe Luer-Lok Tip with BD Precision Glide Needle 20G x 1 (0.9mm x 25mm); Catalog #305064 Product Usage: 1) BD Blunt Plastic Cannula is used to penetrate pre-slit septums covering injection sites, as well as vials designed for penetration with needless IV access cannula. 2) The blunt steel canula will be targeted for exiting applications of pointer cannula, where blunt steel cannula would provide increased safety. Such existing applications include: -Accessing pre-slit/pre-pierced IV septum ports -Providing for fluid transfer -Can be used as tubing adapter 3) The BD single use Hypodermic Syringe is intended for use by healthcare professional for general purpose fluid aspiration/injection.

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