—#132220

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.

FDA product code: FMF — Syringe, Piston
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K110771, K944931, K974363
Affected lot / code info: Catalog #303348, Lot #4209518 Catalog #305064, Lot #4205576 Catalog #309644 Lot #4209524

Why it was recalled

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

Root cause (FDA determination)

Device Design

Action the firm took

BD sent an Urgent Product Advisory Notice letter dated 12/19/2014. The letter identified the affected product, problem and actions to be taken. Customers are advised of the issue with the product and should notify their customers. The attached Product Advisory Response Form should be completed and faxed to 1-866-551-2707. Questions can be directed to 1-866-367-4703.

Recalling firm

Firm: Becton Dickinson & Company
Address: 1 Becton Dr, Franklin Lakes, New Jersey 07417-1815

Distribution

Distribution pattern: US Nationwide Distribution

Timeline

Recall initiated: 2014-12-19
Posted by FDA: 2015-02-05
Terminated: 2015-12-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #132220. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.