Z-1811-2009

BD 60ml Syringe Luer-Lok tip, Sterile, BD, Franklin Lakes, NJ 07417, Made in USA

Name: Z-1811-2009 BD 60ml Syringe Luer-Lok tip, Sterile, BD, Franklin Lakes, NJ 07417, Made in USA
Creator: Becton Dickinson & Company
Published: 2009-07-07
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2009-07-07 / Terminated / root cause: packaging

FDA source

Becton Dickinson & Company began a recall of BD 60ml Syringe Luer-Lok tip, Sterile, BD, Franklin Lakes, NJ 07417, Made in USA on 2009-07-07. The reason FDA records is "Insufficient Seal: Becton Dickinson received complaints of insufficient/open seals on one lot of 60 ml Luer-Lok Syringes". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1811-2009
Status: Terminated
Initiated: 2009-07-07
Posted: 2009-08-12
Terminated: 2009-10-02
Recalling firm: Becton Dickinson & Co
Product: BD 60ml Syringe Luer-Lok tip, Sterile, BD, Franklin Lakes, NJ 07417, Made in USA.
Product code: FMF Syringe, Piston
Reason for recall: Insufficient Seal: Becton Dickinson received complaints of insufficient/open seals on one lot of 60 ml Luer-Lok Syringes.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: Becton Dickinson issued an "Urgent: Product Recall" notice via UPS tracking dated July 7, 2009 to all distributors informing them of the affected product. The firm asked all distributors to identify end customers in an attempt to notify all customers. The firms asks that all affected product be returned. Further questions should be directed to BD Customer Service representatives at 1-888-237-2762.
Quantity in commerce: 133,600 units
Distribution: Nationwide Distribution -- Including states of IL, CA, VA, PA, and FL.
Product codes and lots: Product Number: 309653; Lot Number: 819101A.

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)