Z-1055-2015Class II

BD 10 mL Syringe BD Luer-Lok Tip with Blunt Plastic Cannula, Not for Skin Injection ; Catalog #303348, BD 10...

Name: Z-1055-2015 BD 10 mL Syringe BD Luer-Lok Tip with Blunt Plastic Cannula, Not for Skin Injection ; Catalog #303348, BD 10...
Creator: Becton Dickinson & Company
Published: 2014-12-19
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2014-12-19 / Terminated / root cause: design

FDA source

Becton Dickinson & Company began a recall of 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... on 2014-12-19. FDA classified it as Class II and gives the reason as "The stopper of the 10mL BD Luer-Lok syringe is not properly seated in the syringe". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1055-2015
Classification: Class II
Status: Terminated
Initiated: 2014-12-19
Posted: 2015-02-05
Terminated: 2015-12-07
Recalling firm: Becton Dickinson & Co
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.
Product code: FMF Syringe, Piston
Reason for recall: The stopper of the 10mL BD Luer-Lok syringe is not properly seated in the syringe.
Root cause tag: design
FDA root cause: Device Design
Action: 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.
Quantity in commerce: 564,000 units
Distribution: US Nationwide Distribution
Product codes and lots: Catalog #303348, Lot #4209518 Catalog #305064, Lot #4205576 Catalog #309644 Lot #4209524

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1055-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1055-2015	Class II	Terminated	Voluntary: Firm initiated	2015-02-11	2015-02-04

Product code FMF

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)