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BD 10 mL Syringe BD Luer-Lok Tip with Blunt Plastic… recallZ-1055-2015 · Becton Dickinson & Company · initiated Dec 19, 2014

Class II Terminated All recalls posted in February 2015

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Becton Dickinson & Company or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Device Design

What the company is doing

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.

Recall details

Recall number
Z-1055-2015
Recall class
Class II
Status
Terminated
Initiated by the company
Dec 19, 2014
Posted by the FDA
Feb 5, 2015
Recalling firm
Becton Dickinson & Company
Quantity
564,000 units
Product code
FMF
FDA submissions
K110771, K944931, K974363
Distribution
US Nationwide Distribution

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.

Code information (models, lots, serial numbers)

Catalog #303348, Lot #4209518  Catalog #305064, Lot #4205576  Catalog #309644 Lot #4209524

Other devices under the same FDA submission

82 devices cleared under K110771, K944931, K974363 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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