Recall Z-1055-2015— Becton Dickinson & Company
Class II · Terminated
Class II FDA medical device recall by Becton Dickinson & Company, initiated 2014-12-19, terminated 2015-12-07. It names 3 FDA 510(k) clearances: K110771, K974363, K944931. Product: 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.. Reason: The stopper of the 10mL BD Luer-Lok syringe is not properly seated in the syringe..
- Recalling firm
- Becton Dickinson & Company
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-12-19
- Terminated
- 2015-12-07
- Firm location
- Franklin Lakes, NJ, United States
510(k) clearances named in this recall
3 on FDA's record- K110771 — BD SINGLE USE, HYPODERMIC SYRINGE
- K974363 — BECTON DICKINSON BLUNT PLASTIC CANNULA
- K944931 — BECTON DICKINSON BLUNT STEEL CANNULA
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 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.
Reason for recall
The stopper of the 10mL BD Luer-Lok syringe is not properly seated in the syringe.
Data sourced from openFDA. This site is unofficial and independent of the FDA.