Z-0586-2010

BD 30 ml Syringe; Luer-Lok Tip Catalog # 309650 Becton Dickinson, Franklin Lakes, NJ

Name: Z-0586-2010 BD 30 ml Syringe; Luer-Lok Tip Catalog # 309650 Becton Dickinson, Franklin Lakes, NJ
Creator: Becton Dickinson & Company
Published: 2009-11-23
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2009-11-23 / Terminated / root cause: sterility

FDA source

Becton Dickinson & Company began a recall of BD 30 ml Syringe; Luer-Lok Tip Catalog # 309650 Becton Dickinson, Franklin Lakes, NJ on 2009-11-23. The reason FDA records is "Reports received of open seals on lot # 9175046, BD 30 ml Luer-Lok Syringes. This indicates product sterility may be compromised". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-0586-2010
Status: Terminated
Initiated: 2009-11-23
Posted: 2009-12-29
Terminated: 2010-04-06
Recalling firm: Becton Dickinson & Co
Product: BD 30 ml Syringe; Luer-Lok Tip Catalog # 309650 Becton Dickinson, Franklin Lakes, NJ.
Product code: FMF Syringe, Piston
Reason for recall: Reports received of open seals on lot # 9175046, BD 30 ml Luer-Lok Syringes. This indicates product sterility may be compromised.
Root cause tag: sterility
FDA root cause: Other
Action: Recall notification letters were sent to all distributors on 11/23/2009 by Federal Express. BD called all distributors to get customer lists and will start sending letter to customers commencing on December 8, 2009. Questions are directed to BD Customer Service at 1-888-237-2762, Monday Friday, 8:00 AM 5:00 PM Eastern Time.
Quantity in commerce: 166240 units
Distribution: Distributors nationwide.
Product codes and lots: Catalog Number: 309650; Lot number 9175046

Product code FMF

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)