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Recall Observatory FDA recall evidence

Device 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.

Z-1055-2015

December 19, 2014

Class II

Product summary

Firm
Becton Dickinson & Company
Event
Event 70079
Status
Terminated
Classification
Class II
Quantity
564,000 units
Official record key
device-enforcement:Z-1055-2015

Official wording

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

Code information: Catalog #303348, Lot #4209518 Catalog #305064, Lot #4205576 Catalog #309644 Lot #4209524

Distribution pattern: US Nationwide Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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