Z-2753-2017Class II

BD 3ml Syringer Luer-Lok Tip Catalog #309604 The BD Single Use, Hypodermic Syringe is intended for use by...

Name: Z-2753-2017 BD 3ml Syringer Luer-Lok Tip Catalog #309604 The BD Single Use, Hypodermic Syringe is intended for use by...
Creator: Becton Dickinson & Company
Published: 2016-09-16
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2016-09-16 / Terminated / root cause: manufacturing process

FDA source

Becton Dickinson & Company began a recall of BD 3ml Syringer Luer-Lok Tip Catalog #309604 The BD Single Use, Hypodermic Syringe is intended for use by health care professionals for general purpose fluid... on 2016-09-16. FDA classified it as Class II and gives the reason as "BD identified that several lots did not receive the specified dose of irradiation necessary to meet the Sterility Assurance Level (SAL) required". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2753-2017
Classification: Class II
Status: Terminated
Initiated: 2016-09-16
Posted: 2017-07-19
Terminated: 2018-03-20
Recalling firm: Becton Dickinson & Co
Product: BD 3ml Syringer Luer-Lok Tip Catalog #309604 The BD Single Use, Hypodermic Syringe is intended for use by health care professionals for general purpose fluid aspiration/injection
Product code: FMF Syringe, Piston
Reason for recall: BD identified that several lots did not receive the specified dose of irradiation necessary to meet the Sterility Assurance Level (SAL) required.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: BD sent recall letter/return response form on 9/16/2016.
Quantity in commerce: 1,528,000 units
Distribution: Nationwide Distribution
Product codes and lots: 6061746 2021-02 6082982 2021-02 6089821 2021-03 6117858 2021-04 6117863 2021-04 6117889 2021-04 6117891 2021-04 6146962 2021-04 6173697 2021-05 6173767 2021-06 6173779 2021-06 6208614 2021-07

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2753-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2747-2017	Class II	Terminated	Voluntary: Firm initiated	2017-07-26	2017-07-19
Z-2748-2017	Class II	Terminated	Voluntary: Firm initiated	2017-07-26	2017-07-19
Z-2749-2017	Class II	Terminated	Voluntary: Firm initiated	2017-07-26	2017-07-19
Z-2750-2017	Class II	Terminated	Voluntary: Firm initiated	2017-07-26	2017-07-19
Z-2751-2017	Class II	Terminated	Voluntary: Firm initiated	2017-07-26	2017-07-19
Z-2752-2017	Class II	Terminated	Voluntary: Firm initiated	2017-07-26	2017-07-19
Z-2753-2017	Class II	Terminated	Voluntary: Firm initiated	2017-07-26	2017-07-19

Product code FMF

K110771Class IIBd Single Use, Hypodermic SyringeBecton, Dickinson and Company / cleared 2011-05-13

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)